Burosumab

also known as KRN23 · burosumab-twza · Crysvita

Developed for: X-linked hypophosphatemic rickets · epidermal nevus syndrome · Oncogenic osteomalacia · fibrous dysplasia · hypophosphatemia · hypophosphatemic bone disease · hypophosphatemic rickets
Investigated by: Kyowa Kirin, Inc. · Ultragenyx Pharmaceutical Inc · Kyowa Hakko Kirin Pharma, Inc. · Kyowa Kirin Pharmaceutical Development Ltd · Bicetre Hospital · Children's National Research Institute
+6 more
· Laura Tosi · National Institute of Dental and Craniofacial Research (NIDCR) · Redwood Dermatology Sciences · University of Alabama at Birmingham · Wuerzburg University Hospital · Yale University

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed hypophosphatemic rickets and hyperparathyroidism 1 milestone
Filed	Japan (PMDA)	—	hypophosphatemic rickets and hyperparathyroidism	2019-01-07	“it has filed an application for manufacturing and marketing approval with Japan's Ministry of Health, Labor and Welfare (MHLW) for burosumab (code name: KRN23)” kyowakirin.com ↗
Filed X-linked hypophosphatemic rickets 2 milestones
Filed	EU (EMA)	CRYSVITA	X-linked hypophosphatemic rickets	2019-11-05	“EMA has accepted an application for the expanded use of CRYSVITA® (burosumab) for the treatment of X-linked hypophosphataemia (XLH) in adult patients.” kyowakirin.com ↗ “EMA accepted an application for the expanded use of CRYSVITA (burosumab) for the treatment of XLH in adult patients.” kyowakirin.com ↗ “The MAA was submitted and accepted for review by the European Medicines Agency (EMA) in December 2016.” ultragenyx.com ↗
Filed	US (FDA)	—	X-linked hypophosphatemic rickets	2017-08-24	“Ultragenyx has submitted a Biologics License Application (BLA) with the Food and Drug Administration (FDA) for burosumab to treat X-Linked Hypophosphatemia (XLH)” ultragenyx.com ↗ “The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for burosumab” ultragenyx.com ↗ “The U.S. FDA accepted the Biologics License Application (BLA) for burosumab” ultragenyx.com ↗
Approved Indication not stated 3 milestones
Label expansions (3)	US (FDA)	CRYSVITA	—	2019-09-27 – 2026-04-23	fda.gov ↗
Approved	US (FDA)	CRYSVITA	—	2018-04-17	fda.gov ↗
Approved	EU (EMA)	Crysvita	—	2018-02-19	europa.eu ↗

Trials 26

today

EU approved 2018

US approved 2018

NCT05509595 · Ph 2 NCT05357573 · Ph 4 NCT04842032 · Ph 4 NCT04842019 · Ph 4 NCT04695860 · Ph 3 NCT04320316 · Ph 4 NCT04188964 · Ph 1/2 NCT04146935 · Ph 4 NCT03993821 · Ph 0 NCT03920072 · Ph 3 NCT04419363 · Ph 4 NCT03581591 · Ph 3 NCT04308096 · Ph 3 NCT03233126 · Ph 3 NCT02915705 · Ph 3 NCT02750618 · Ph 2 NCT02722798 · Ph 2 NCT02537431 · Ph 3 NCT02526160 · Ph 3 NCT02304367 · Ph 2 NCT02312687 · Ph 2 NCT02181764 · Ph 1 NCT02163577 · Ph 2 NCT01571596 · Ph 1/2 NCT01340482 · Ph 1/2 NCT00830674 · Ph 1

2009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT03993821	Jul 2019 → Oct 2022	epidermal nevus syndrome, hypophosphatemic bone disease	Laura Tosi	Unknown	No outcome recorded
Phase 12 trials
Phase 1	NCT02181764	Jul 2014 → Jun 2015	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	No outcome recorded
Phase 1	NCT00830674	Dec 2008 → Dec 2011	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	No outcome recorded
Phase 1/23 trials
Phase 1/2	NCT04188964	Feb 2020 → Oct 2023	X-linked hypophosphatemic rickets	Kyowa Kirin Pharmaceutical Development Ltd	Completed	No outcome recorded
Phase 1/2	NCT01571596	Feb 2012 → Sep 2013	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	No outcome recorded
Phase 1/2	NCT01340482	Apr 2011 → May 2013	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	No outcome recorded
Phase 26 trials · 2 met primary
Phase 2	NCT05509595	Dec 2022 → Nov 2024	fibrous dysplasia	National Institute of Dental and Craniofacial Research (NIDCR)	Completed	No outcome recorded
Phase 2	NCT02750618	May 2016 → Apr 2017	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	Met primary
Phase 2	NCT02722798	Apr 2016 → Jul 2017	Oncogenic osteomalacia	Kyowa Kirin, Inc.	Completed	No outcome recorded
Phase 2	NCT02304367	Mar 2015 → Jul 2017	Oncogenic osteomalacia, epidermal nevus syndrome	Kyowa Kirin, Inc.	Completed	No outcome recorded
Phase 2	NCT02312687	Jan 2015 → Nov 2018	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	Mixed
Phase 2	NCT02163577	Jul 2014 → Oct 2018	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	Met primary
Phase 38 trials · 3 met primary
Phase 3	NCT04695860	Jan 2021 → Mar 2023	X-linked hypophosphatemic rickets	Wuerzburg University Hospital	Completed	No outcome recorded
Phase 3	NCT03920072	Mar 2019 → Apr 2022	X-linked hypophosphatemic rickets	Kyowa Kirin Pharmaceutical Development Ltd	Completed	No outcome recorded
Phase 3	NCT03581591	Jan 2018 → Dec 2019	chronic pain syndrome, hypophosphatemia, hypophosphatemic rickets	Redwood Dermatology Sciences	Completed	No outcome recorded
Phase 3	NCT04308096	Jan 2018 → Dec 2020	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	No outcome recorded
Phase 3	NCT03233126	Jul 2017 → Feb 2020	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	No outcome recorded
Phase 3	NCT02915705	Sep 2016 → Feb 2018	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	Met primary
Phase 3	NCT02537431	Dec 2015 → Aug 2017	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	Met primary
Phase 3	NCT02526160	Oct 2015 → Dec 2016	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	Met primary
Phase 46 trials
Phase 4	NCT05357573	Sep 2022 → Nov 2023	Oncogenic osteomalacia	Kyowa Kirin, Inc.	Completed	No outcome recorded
Phase 4	NCT04842032	Nov 2021 → Dec 2023	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	No outcome recorded
Phase 4	NCT04842019	Sep 2021 → Aug 2023	X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Completed	No outcome recorded
Phase 4	NCT04320316	Jul 2020 → Jul 2021	epidermal nevus syndrome	University of Alabama at Birmingham	Completed	No outcome recorded
Phase 4	NCT04146935	Nov 2019 → Aug 2022	X-linked hypophosphatemic rickets	Yale University	Completed	No outcome recorded
Phase 4	NCT04419363	Mar 2018 → Mar 2019	Gaucher ichthyosis restrictive dermopathy, X-linked hypophosphatemic rickets	Bicetre Hospital	Unknown	No outcome recorded
Comparator or background therapy1 trial
—	NCT03775187 Background	—	Oncogenic osteomalacia, X-linked hypophosphatemic rickets	Kyowa Kirin, Inc.	Available	No outcome recorded

News releases announcing trial results or a regulatory action · 66

Date	Issuer	Release
2021-09-24	Kyowa Kirin, Inc.	Results Long-term CRYSVITA® ▼ (burosumab) treatment reduces the burden of disease in adults with X-Linked Hypophosphataemia (XLH), a rare genetic metabolic bone disease Extended CRYSVITA therapy significantly improves pain, stiffness, fatigue and physical and ambulatory function compared to baseline after 96 weeks kyowakirin.com ↗ At week 96, the study showed statistically significant improvements in PROs, including the Western Ontario and the McMaster Universities Osteoarthritis Index (WOMAC), Brief Pain Inventory-Short Form (BPI-SF) and Brief Fatigue Inventory (BFI), compared to baseline.
2020-12-04	Kyowa Kirin, Inc.	Regulatory Kyowa Kirin Announces Crysvita® Now Reimbursed for Self-Injection in Japan kyowakirin.com ↗
2020-10-05	Kyowa Kirin, Inc.	Regulatory Kyowa Kirin Announces European Commission (EC) Approval of CRYSVITA® (burosumab) for the Treatment of X-Linked Hypophosphataemia (XLH) in Older Adolescents and AdultsMore people in Europe are now eligible for treatment with CRYSVITA, the only therapy that targets the underlying pathophysiology of XLH, a rare, life-long genetic disease that causes abnormalities in the bones, muscles and joints1,2,3 kyowakirin.com ↗ Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin) today announced that the European Commission (EC) has approved CRYSVITA® (burosumab) for use in older adolescents and adults with the rare disease X-linked hypophosphataemia (XLH).
2020-07-27	Kyowa Kirin, Inc.	Regulatory Kyowa Kirin Receives Positive CHMP Opinion for the Expanded Use of CRYSVITA® (burosumab) to Include Older Adolescents and Adults for the Treatment of X-Linked Hypophosphataemia (XLH)XLH is a rare, life-long genetic disease that causes abnormalities in the bones, muscles and joints1,2,3 kyowakirin.com ↗ Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the expanded approval of CRYSVITA® (burosumab) to include older adolescents and adults living with the rare disease X-linked hypophosphataemia (XLH).
2020-06-18	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx and Kyowa Kirin Announce U.S. FDA Approval of Crysvita® (burosumab) for the Treatment of Tumor-Induced Osteomalacia (TIO) ultragenyx.com ↗ The FDA approval of Crysvita marks the first treatment option that addresses the cause of the severe hypophosphatemia and osteomalacia resulting from these rare tumors,
2020-02-27	Kyowa Kirin, Inc.	Regulatory Ultragenyx and Kyowa Kirin Announce FDA Acceptance and Priority Review Designation of Supplemental Biologics License Application for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO) kyowakirin.com ↗ today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Crysvita® (burosumab) for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (tumor-induced osteomalacia; TIO) that cannot be curatively resected or localized.
2020-02-27	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx and Kyowa Kirin Announce FDA Acceptance and Priority Review Designation of Supplemental Biologics License Application for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO) ultragenyx.com ↗
2020-02-25	Kyowa Kirin, Inc.	Regulatory Kyowa Kirin Announces Approval of CRYSVITA® (burosumab) in Switzerland for the Treatment of Adults and Children with X-Linked Hypophosphatemia (XLH) CRYSVITA is the first and only treatment for XLH that targets the underlying cause of the disease kyowakirin.com ↗ Kyowa Kirin Co., Ltd., (Kyowa Kirin) today announced the approval of CRYSVITA (burosumab) by Swissmedic (dispensing category B) for the treatment of adults, adolescents and children (1 year of age and older) with X-linked hypophosphatemia (XLH), a rare genetic disease that causes abnormalities in the bones, muscles and joints.
2020-01-14	Kyowa Kirin, Inc.	Regulatory Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO) kyowakirin.com ↗
2020-01-13	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO) ultragenyx.com ↗
2019-11-05	Kyowa Kirin, Inc.	Regulatory European Medicines Agency Accepts Kyowa Kirin’s Application for the Expanded Use of CRYSVITA® (burosumab) for the Treatment of Adults with X-Linked Hypophosphataemia kyowakirin.com ↗ Kyowa Kirin Co., Ltd., (Kyowa Kirin) today announced that the European Medicines Agency (EMA) has accepted an application for the expanded use of CRYSVITA® (burosumab) for the treatment of X-linked hypophosphataemia (XLH) in adult patients.
2019-09-30	Kyowa Kirin, Inc.	Regulatory Ultragenyx and Kyowa Kirin Announce U.S. FDA Approves Label Update for Crysvita® (burosumab) for the Treatment of X-Linked Hypophosphatemia (XLH) Expanded Label Includes Additional Clinical Data Highlighting Superiority Over Conventional Therapy for Pediatric Patients and Extends Current U.S. Indication to Patients Aged Six Months and Older Expanded Label Includes Data Demonstrating Improvement in Stiffness, Continued Further Healing of Fractures and Maintenance of Efficacy with Longer-Term Treatment in Adults kyowakirin.com ↗ Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Crysvita® (burosumab).
2019-09-30	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx and Kyowa Kirin Announce U.S. FDA Approves Label Update for Crysvita® (burosumab) for the Treatment of X-Linked Hypophosphatemia (XLH) ultragenyx.com ↗ Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Crysvita® (burosumab).
2019-09-20	Kyowa Kirin, Inc.	Regulatory Kyowa Kirin Announces Approval of Crysvita® (burosumab) for the Treatment of FGF23-related Hypophosphatemic Rickets and Osteomalacia in Japan kyowakirin.com ↗ Tokyo, Japan, September 20th, 2019 --- Kyowa Kirin Co., Ltd., (TYO: 4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") today announced that Crysvita® (burosumab) has been approved by Japan's Ministry of Health, Labor and Welfare (MHLW) for the treatment of FGF23-related hypophosphatemic rickets and osteomalacia.
2019-03-26	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx Announces Approval of Crysvita® (burosumab) in Brazil for the Treatment of X-linked Hypophosphatemia (XLH) in Adults and Children ultragenyx.com ↗ Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, today announced that Brazil’s National Health Surveillance Agency (ANVISA) has approved Crysvita® (burosumab) for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients one year of age and older.
2019-02-15	Kyowa Kirin, Inc.	Results Ultragenyx and Kyowa Kirin Announce Positive 64-Week Results for Crysvita® (burosumab) from Phase 3 Study in Children with X-linked Hypophosphatemia (XLH) Results Confirm and Extend 40-Week Findings that Treatment with Crysvita is Superior to Conventional Therapy kyowakirin.com ↗ The new results showed that Crysvita was superior to conventional therapy for all key efficacy endpoints, showing a meaningful improvement in rickets severity, lower limb deformity, growth, and physical functioning as demonstrated by increases in distance walked.
2019-02-14	Ultragenyx Pharmaceutical Inc	Results Ultragenyx and Kyowa Kirin Announce Positive 64-Week Results for Crysvita® (burosumab) from Phase 3 Study in Children with X-linked Hypophosphatemia (XLH) ultragenyx.com ↗ today announced positive results of a 64-week efficacy and safety analysis of the randomized active-controlled Phase 3 study of Crysvita® (burosumab) in children with X-linked hypophosphatemia (XLH) compared with oral phosphate and active vitamin D (current conventional therapy).
2019-01-07	Kyowa Kirin, Inc.	Regulatory Kyowa Hakko Kirin Submits Application for Approval of Burosumab for FGF23-related Hypophosphatemic Rickets and Osteomalacia in Japan kyowakirin.com ↗ Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and COO: Masashi Miyamoto, "Kyowa Hakko Kirin") today announced that it has filed an application for manufacturing and marketing approval with Japan's Ministry of Health, Labor and Welfare (MHLW) for burosumab (code name: KRN23) to treat FGF23-related hypophosphatemic rickets and osteomalacia.
2018-12-06	Kyowa Kirin, Inc.	Regulatory Ultragenyx and Kyowa Kirin Announce Health Canada Approval of Crysvita™ (burosumab injection) for the Treatment of X-linked Hypophosphatemia (XLH) in Adults and Children First Approved Treatment for XLH in Canada that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease kyowakirin.com ↗ Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, Kyowa Hakko Kirin Co. Ltd, (Kyowa Hakko Kirin), and Kyowa Kirin International PLC (Kyowa Kirin International) today announced that Crysvita™ (burosumab injection) has been approved by Health Canada for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients one year of age and older.
2018-12-06	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx and Kyowa Kirin Announce Health Canada Approval of Crysvita™ (burosumab injection) for the Treatment of X–linked Hypophosphatemia (XLH) in Adults and Children ultragenyx.com ↗ Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, Kyowa Hakko Kirin Co. Ltd, (Kyowa Hakko Kirin), and Kyowa Kirin International PLC ( Kyowa Kirin International ) today announced that Crysvita™ (burosumab injection) has been approved by Health Canada for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients one year of age and older.
2018-05-24	Kyowa Kirin, Inc.	Results Ultragenyx and Kyowa Kirin Announce Publication of Phase 2 Study Results Demonstrating that Crysvita® (burosumab) Improved Outcomes in Children with X-linked Hypophosphatemia in the New England Journal of MedicinePediatric Study Demonstrated Improvements in Rickets Severity, Growth, Pain and Physical Activity in Children with Debilitating, Lifelong Hereditary Disease kyowakirin.com ↗ The results demonstrated that Crysvita improved rickets severity, growth, pain and physical function, and increased serum phosphorus and renal phosphate reabsorption.
2018-05-23	Ultragenyx Pharmaceutical Inc	Results Ultragenyx and Kyowa Kirin Announce Publication of Phase 2 Study Results Demonstrating that Crysvita® (burosumab) Improved Outcomes in Children with X-linked Hypophosphatemia in the New England Journal of Medicine ultragenyx.com ↗ The results demonstrated that Crysvita improved rickets severity, growth, pain and physical function, and increased serum phosphorus and renal phosphate reabsorption.
2018-05-17	Kyowa Kirin, Inc.	Results Ultragenyx and Kyowa Kirin Announce Topline Phase 3 Study Results Demonstrating Superiority of Crysvita® (burosumab) Treatment to Oral Phosphate and Active Vitamin D in Children with X-Linked Hypophosphatemia (XLH)Substantial Healing of Rickets Observed in 72% of Patients Treated with Crysvita Comparedto 6% of Patients Receiving Conventional Therapy at 40 Weeks kyowakirin.com ↗ The study also showed improvement in important metabolic and functional measures with Crysvita treatment, and a safety profile similar to that observed in other Crysvita pediatric XLH studies.
2018-05-17	Ultragenyx Pharmaceutical Inc	Results Ultragenyx and Kyowa Kirin Announce Topline Phase 3 Study Results Demonstrating Superiority of Crysvita® (burosumab) Treatment to Oral Phosphate and Active Vitamin D in Children with X-Linked Hypophosphatemia (XLH) ultragenyx.com ↗ The study also showed improvement in important metabolic and functional measures with Crysvita treatment, and a safety profile similar to that observed in other Crysvita pediatric XLH studies.
2018-04-18	Kyowa Kirin, Inc.	Regulatory Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita®(burosumab-twza) for the Treatment of Children and Adults with X–Linked Hypophosphatemia (XLH)First Approved Therapy for XLH in the U.S.; Only Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease kyowakirin.com ↗
2018-04-17	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita® (burosumab-twza) for the Treatment of Children and Adults with X–Linked Hypophosphatemia (XLH) ultragenyx.com ↗ “Patients now have an approved breakthrough therapy that can help correct the underlying disease, transforming the treatment of XLH and reducing related bone disease in both children and adults living with this disease,”
2018-02-23	Kyowa Kirin, Inc.	Regulatory Kyowa Kirin and Ultragenyx Announce Crysvita® (burosumab) Receives Conditional Marketing Authorisation in Europe for the Treatment of X–Linked Hypophosphatemia in ChildrenCrysvita is the First Treatment for XLH that Targets the Underlying Cause of the DiseaseCrysvita Acknowledged by European Medicines Agency as anOutstanding Contribution to Public Health kyowakirin.com ↗ This is the first regulatory approval globally for Crysvita, an anti-FGF23 fully human monoclonal antibody that is the first treatment to target the underlying pathophysiology of XLH.
2018-02-23	Ultragenyx Pharmaceutical Inc	Regulatory Kyowa Kirin and Ultragenyx Announce Crysvita® (burosumab) Receives Conditional Marketing Authorization in Europe for the Treatment of X–Linked Hypophosphatemia in Children ultragenyx.com ↗ This is the first regulatory approval globally for Crysvita, an anti-FGF23 fully human monoclonal antibody that is the first treatment to target the underlying pathophysiology of XLH.
2017-12-15	Kyowa Kirin, Inc.	Regulatory Ultragenyx and Kyowa Kirin Announce Burosumab Receives Positive CHMP Opinion for the Treatment of X-Linked Hypophosphatemia in ChildrenIf approved, Burosumab would be the first targeted disease-modifying treatment for XLH kyowakirin.com ↗
2017-12-15	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx and Kyowa Kirin Announce Burosumab Receives Positive CHMP Opinion for the Treatment of X-Linked Hypophosphatemia in Children ultragenyx.com ↗
2017-12-04	Kyowa Kirin, Inc.	Results Ultragenyx and Kyowa Kirin Announce Positive 48-Week Data from Adult Phase 3 Study of Burosumab (KRN23) in X-Linked HypophosphatemiaFurther improvement in disease symptoms and fracture healing observed through 48 weeks of treatment with burosumab kyowakirin.com ↗ Treatment with burosumab for 48 weeks showed sustained maintenance of normal serum phosphorus levels and further improvement in stiffness, physical function and pain.
2017-12-04	Ultragenyx Pharmaceutical Inc	Results Ultragenyx and Kyowa Kirin Announce Positive 48-Week Data from Adult Phase 3 Study of Burosumab (KRN23) in X-Linked Hypophosphatemia ultragenyx.com ↗ Treatment with burosumab for 48 weeks showed sustained maintenance of normal serum phosphorus levels and further improvement in stiffness, physical function and pain.
2017-11-01	Kyowa Kirin, Inc.	Regulatory Ultragenyx and Kyowa Hakko Kirin Announce FDA Not Currently Planning to Hold Advisory Committee Meeting for Burosumab Biologics License ApplicationRegulatory Review Process Proceeding as Expected; PDUFA date of April 17, 2018 kyowakirin.com ↗
2017-11-01	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx and Kyowa Hakko Kirin Announce FDA Not Currently Planning to Hold Advisory Committee Meeting for Burosumab Biologics License Application ultragenyx.com ↗
2017-10-10	Kyowa Kirin, Inc.	Regulatory Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab's Biologics License Application kyowakirin.com ↗
2017-10-10	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab's Biologics License Application ultragenyx.com ↗
2017-09-12	Kyowa Kirin, Inc.	Results Ultragenyx and Kyowa Hakko Kirin Announce Additional Burosumab Data in X-Linked Hypophosphatemia (XLH) and Tumor-Induced Osteomalacia (TIO) at ASBMRPositive data in bone disease in pediatric XLH patients under 5 years old and in TIO patients kyowakirin.com ↗ "The results from the under five year old study support the value of early treatment initiation with burosumab in XLH patients in treating bone disease," said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx.
2017-09-11	Ultragenyx Pharmaceutical Inc	Results Ultragenyx and Kyowa Hakko Kirin Announce Additional Burosumab Data in X-Linked Hypophosphatemia (XLH) and Tumor-Induced Osteomalacia (TIO) at ASBMR ultragenyx.com ↗
2017-08-24	Kyowa Kirin, Inc.	Regulatory Ultragenyx and Kyowa Hakko Kirin Announce Submission of Burosumab's Biologics License Application in the US kyowakirin.com ↗ today announced that Ultragenyx has submitted a Biologics License Application (BLA) with the Food and Drug Administration (FDA) for burosumab to treat X-Linked Hypophosphatemia (XLH) in the US.
2017-08-24	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx and Kyowa Hakko Kirin Announce Submission of Burosumab's Biologics License Application in the US ultragenyx.com ↗
2017-07-28	Kyowa Kirin, Inc.	Regulatory Kyowa Hakko Kirin and Kyowa Kirin International Announce Regulatory Updates for Burosumab in the US and EU. kyowakirin.com ↗ The FDA's Office of Orphan Drug Development (OOPD) has recently designated burosumab for the treatment of X-linked hypophosphatemia (XLH) as a drug for a "rare pediatric disease".
2017-06-23	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx Provides Regulatory Update on Burosumab (KRN23) ultragenyx.com ↗ At the meeting, the FDA agreed that the BLA can be submitted based on available clinical data and confirmed that both pediatric and adult indications would be included in the review.
2017-04-19	Kyowa Kirin, Inc.	Results Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International Announce Positive 24-Week Data from Adult Phase 3 Study of Burosumab (KRN23) in X-Linked HypophosphatemiaStudy met primary endpoint of serum phosphorus response and key secondary endpoint of stiffness improvementUltragenyx to host conference call today at 4:30pm ET to discuss results kyowakirin.com ↗ Patients treated with burosumab demonstrated a statistically significant improvement in serum phosphorus levels, with 94% of patients achieving normal levels compared to 8% on placebo (p<0.0001).
2017-04-18	Ultragenyx Pharmaceutical Inc	Results Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International Announce Positive 24-Week Data from Adult Phase 3 Study of Burosumab (KRN23) in X-Linked Hypophosphatemia ultragenyx.com ↗ Patients treated with burosumab demonstrated a statistically significant improvement in serum phosphorus levels, with 94% of patients achieving normal levels compared to 8% on placebo (p0.0001).
2017-04-06	Kyowa Kirin, Inc.	Results Ultragenyx and Kyowa Kirin International Announce Positive Data from Paediatric Phase 2 Studies of Burosumab (KRN23) in X-Linked HypophosphatemiaSustained reduction in bone disease and improvement in growth through 64 weeks of treatment and sustained effect on bone mineral metabolites in patients under 5 years old kyowakirin.com ↗ The data demonstrated that serum phosphorus levels, rickets, growth rates, and other functional outcomes improved with burosumab, and these treatment effects were sustained through 64 weeks of treatment.
2017-04-06	Ultragenyx Pharmaceutical Inc	Results Ultragenyx and Kyowa Kirin International Announce Positive Data from Pediatric Phase 2 Studies of Burosumab (KRN23) in X-Linked Hypophosphatemia ultragenyx.com ↗ Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) and Kyowa Kirin International PLC (KKI), a wholly owned subsidiary of Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin), today announced positive 64-week data from a pediatric Phase 2 study of burosumab (KRN23) for the treatment of X-linked hypophosphatemia (XLH) in children aged five to 12 years of age.
2017-01-05	Kyowa Kirin, Inc.	Regulatory Ultragenyx and Kyowa Kirin International Announce Marketing Authorisation Application for KRN23 Filed and Accepted for Review by European Medicines Agency kyowakirin.com ↗ The MAA was filed and accepted in late 2016, and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in the second half of 2017.
2017-01-05	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx and Kyowa Kirin International Announce Marketing Authorization Application for KRN23 Filed and Accepted for Review by European Medicines Agency ultragenyx.com ↗ The MAA was filed and accepted in late 2016, and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in the second half of 2017.
2016-09-20	Kyowa Kirin, Inc.	Results Kyowa Hakko Kirin Announces Positive Interim Data from Pediatric and Adult Phase 2 Studies of KRN23 in X-Linked HypophosphatemiaPediatric study demonstrates substantial reduction in bone disease and improvement in growth rates Adult study demonstrates increase in serum phosphorus and provides evidence of clinical improvement kyowakirin.com ↗ Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") today announced positive interim data from the ongoing pediatric Phase 2 study of KRN23 for the treatment of X-linked hypophosphatemia (XLH), demonstrating that serum phosphorus levels, rickets, growth rates and other functional outcomes improved with continued KRN23 treatment.
2016-09-20	Kyowa Kirin, Inc.	Results Kyowa Hakko Kirin Announces Positive Interim Data from Phase 2 Study of KRN23 for the Treatment of Tumor-Induced Osteomalacia kyowakirin.com ↗ Interim data at 24 weeks from the first eight patients, including one patient with epidermal nevus syndrome (ENS), demonstrated that KRN23 improved serum phosphorus levels and bone metabolism measures.
2016-09-19	Ultragenyx Pharmaceutical Inc	Results Ultragenyx Reports Positive Interim Data from Pediatric and Adult Phase 2 Studies of KRN23 in X-Linked Hypophosphatemia ultragenyx.com ↗ Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced positive interim data from the ongoing pediatric Phase 2 study of KRN23 for the treatment of X-linked hypophosphatemia (XLH), demonstrating that serum phosphorus levels, rickets, growth rates and other functional outcomes improved with continued KRN23 treatment.
2016-09-18	Ultragenyx Pharmaceutical Inc	Results Ultragenyx Reports Positive Interim Data from Phase 2 Study of KRN23 for the Treatment of Tumor-Induced Osteomalacia ultragenyx.com ↗ Interim data at 24 weeks from the first eight patients, including one patient with epidermal nevus syndrome (ENS), demonstrated that KRN23 improved serum phosphorus levels and bone metabolism measures.
2016-06-28	Kyowa Kirin, Inc.	Regulatory US Food and Drug Administration Granted Breakthrough Therapy Designation for KRN23 for Pediatric X-Linked Hypophosphatemia kyowakirin.com ↗ Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") today announced KRN23, an investigational recombinant fully human monoclonal IgG1 antibody against the phosphaturic hormone fibroblast growth factor 23(FGF23), has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of X-linked hypophosphatemia (XLH) in pediatric patients one year of age and older.
2016-06-28	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx Receives Breakthrough Therapy Designation for KRN23 in Pediatric Patients with X-Linked Hypophosphatemia ultragenyx.com ↗
2016-04-21	Kyowa Kirin, Inc.	Results Kyowa Hakko Kirin Announces Positive Interim Data from Phase 2 Study of KRN23 for the Treatment of Tumor-Induced Osteomalacia kyowakirin.com ↗ Initial data from the first eight patients in the study, including one patient with epidermal nevus syndrome (ENS), demonstrated that KRN23 improved serum phosphorus levels and other bone metabolism measures.
2016-04-21	Ultragenyx Pharmaceutical Inc	Results Ultragenyx Reports Positive Interim Data from Phase 2 Study of KRN23 for the Treatment of Tumor-Induced Osteomalacia ultragenyx.com ↗ Initial data from the first eight patients in the study, including one patient with epidermal nevus syndrome (ENS), demonstrated that KRN23 improved serum phosphorus levels and other bone metabolism measures.
2015-12-02	Kyowa Kirin, Inc.	Results Kyowa Hakko Kirin Announces Positive Interim 40-Week Data from Pediatric Phase 2 Study of KRN23 in X-Linked HypophosphatemiaSubstantial reduction in bone disease demonstrated with two different instruments kyowakirin.com ↗ Importantly, patients with more severe disease at baseline had greater improvements on treatment with KRN23.
2015-12-02	Ultragenyx Pharmaceutical Inc	Results Ultragenyx Reports Positive Interim 40-Week Data From Pediatric Phase 2 Study of KRN23 in X-Linked Hypophosphatemia ultragenyx.com ↗ Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced positive interim data through 40 weeks from the first 36 patients in the ongoing pediatric Phase 2 study of KRN23 for the treatment of X-linked hypophosphatemia (XLH).
2015-07-09	Ultragenyx Pharmaceutical Inc	Results Ultragenyx Releases Positive Interim 40-Week Bone Treatment Data From Ongoing Pediatric Phase 2 Study of KRN23 in X-Linked Hypophosphatemia ultragenyx.com ↗ Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced positive interim data from the first 12 patients in the ongoing pediatric Phase 2 study for its recombinant human monoclonal antibody KRN23 against fibroblast growth factor 23 (FGF23) for the treatment of X-linked hypophosphatemia (XLH).
2015-06-02	Ultragenyx Pharmaceutical Inc	Results Ultragenyx Releases Positive 16-Week Interim Data From Pediatric Phase 2 Study of KRN23 in X-Linked Hypophosphatemia ultragenyx.com ↗ After 16 weeks of dose-titration, all 36 patients had increases in serum phosphorus levels from baseline.
2014-10-30	Ultragenyx Pharmaceutical Inc	Regulatory Ultragenyx Granted EU Orphan Drug Designation for KRN23 for the Treatment of X-Linked Hypophosphatemia ultragenyx.com ↗ today announced that the European Commission has granted orphan medicinal product designation for recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 (KRN23 or UX023) for the treatment of X-linked hypophosphatemia (XLH).
2014-09-16	Kyowa Kirin, Inc.	Results Announcement of Results from Long-Term Phase 1/2 Study of KRN23 in X-linked Hypophosphatemia in Adults kyowakirin.com ↗ Data from the KRN23 INT-002 study demonstrated that the increases in serum phosphorus levels, urinary phosphorous reabsorption, and 1,25 dihydroxy vitamin D3 levels observed in the initial KRN23 INT-001 study were generally sustained during the 12-month extension.
2014-09-15	Ultragenyx Pharmaceutical Inc	Results Ultragenyx Announces Positive Results From a Long-Term Phase 1/2 Study of KRN23 in Adult Patients With X-Linked Hypophosphatemia ultragenyx.com ↗
2014-06-25	Kyowa Kirin, Inc.	Results Announcement of Results from a Multiple Dose Phase 1/2 Study of a Human Monoclonal Anti-FGF23 Antibody (KRN23) in X-linked Hypophosphatemia in Adults kyowakirin.com ↗ Repeat doses with KRN23 over four months led to an increase in serum phosphorus in 100% of patients, with approximately 89% of patients reaching the low end of the normal range.
2014-06-24	Ultragenyx Pharmaceutical Inc	Results Ultragenyx Announces Results From Phase 1/2 Study of KRN23 in X-linked Hypophosphatemia in Adults ultragenyx.com ↗ The efficacy data from the Phase 1/2 study demonstrate that blocking excess FGF23 increases urinary phosphorus reabsorption, serum phosphorus levels, and 1,25 dihydroxy vitamin D levels.
2013-10-07	Kyowa Kirin, Inc.	Results Announcement of Results from a Single Dose Phase 1 Study of a Human Monoclonal Anti-FGF23 Antibody (KRN23) in X-linked Hypophosphatemia in Adults kyowakirin.com ↗ The study showed single doses of either IV or SC KRN23 increased serum phosphate level compared to placebo for higher doses (p<0.01).

All press releases naming this drug 96 releases

Date	Issuer	Release
2025-11-04	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces Sale of a Portion of Future North American Royalties on Crysvita® (burosumab) for $400 Million to OMERS Life Sciences ultragenyx.com ↗
2022-07-14	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces Sale of a Portion of Future North American Royalties on Crysvita® (burosumab) for $500 Million to OMERS Capital Markets ultragenyx.com ↗
2022-01-10	Ultragenyx Pharmaceutical Inc	Ultragenyx Reports Preliminary 2021 Revenue and 2022 Revenue Guidance for Crysvita® in Ultragenyx Territories* And Dojolvi® Globally; Provides Pipeline Updates and 2022 Milestones ultragenyx.com ↗
2021-10-01	Kyowa Kirin, Inc.	Kyowa Kirin announces the presentations about Crysvita® (burosumab) at American Society for Bone and Mineral Research (ASBMR) 2021 Annual Meeting kyowakirin.com ↗
2021-09-27	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces Crysvita® (burosumab) and UX143 (setrusumab) Data Presentations at Upcoming American Society for Bone and Mineral Research (ASBMR) 2021 Annual Meeting ultragenyx.com ↗
2021-09-24	Kyowa Kirin, Inc.	Long-term CRYSVITA® ▼ (burosumab) treatment reduces the burden of disease in adults with X-Linked Hypophosphataemia (XLH), a rare genetic metabolic bone disease Extended CRYSVITA therapy significantly improves pain, stiffness, fatigue and physical and ambulatory function compared to baseline after 96 weeks kyowakirin.com ↗
2021-01-11	Ultragenyx Pharmaceutical Inc	Ultragenyx Reports Preliminary 2020 Revenue and 2021 Revenue Guidance for Crysvita in Ultragenyx Territories ultragenyx.com ↗
2020-12-04	Kyowa Kirin, Inc.	Kyowa Kirin Announces Crysvita® Now Reimbursed for Self-Injection in Japan kyowakirin.com ↗
2020-10-05	Kyowa Kirin, Inc.	Kyowa Kirin Announces European Commission (EC) Approval of CRYSVITA® (burosumab) for the Treatment of X-Linked Hypophosphataemia (XLH) in Older Adolescents and AdultsMore people in Europe are now eligible for treatment with CRYSVITA, the only therapy that targets the underlying pathophysiology of XLH, a rare, life-long genetic disease that causes abnormalities in the bones, muscles and joints1,2,3 kyowakirin.com ↗
2020-07-27	Kyowa Kirin, Inc.	Kyowa Kirin Receives Positive CHMP Opinion for the Expanded Use of CRYSVITA® (burosumab) to Include Older Adolescents and Adults for the Treatment of X-Linked Hypophosphataemia (XLH)XLH is a rare, life-long genetic disease that causes abnormalities in the bones, muscles and joints1,2,3 kyowakirin.com ↗
2020-06-18	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce U.S. FDA Approval of Crysvita® (burosumab) for the Treatment of Tumor-Induced Osteomalacia (TIO) ultragenyx.com ↗
2020-02-27	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce FDA Acceptance and Priority Review Designation of Supplemental Biologics License Application for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO) kyowakirin.com ↗
2020-02-27	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce FDA Acceptance and Priority Review Designation of Supplemental Biologics License Application for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO) ultragenyx.com ↗
2020-02-25	Kyowa Kirin, Inc.	Kyowa Kirin Announces Approval of CRYSVITA® (burosumab) in Switzerland for the Treatment of Adults and Children with X-Linked Hypophosphatemia (XLH) CRYSVITA is the first and only treatment for XLH that targets the underlying cause of the disease kyowakirin.com ↗
2020-01-14	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO) kyowakirin.com ↗
2020-01-13	Ultragenyx Pharmaceutical Inc	Ultragenyx Reports Preliminary 2019 Revenue and Provides 2020 Crysvita Revenue Guidance ultragenyx.com ↗
2020-01-13	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO) ultragenyx.com ↗
2019-12-18	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces Sale of Future European Royalties on Crysvita® (burosumab) for $320 Million to Royalty Pharma ultragenyx.com ↗
2019-12-02	Kyowa Kirin, Inc.	Kyowa Kirin Announces Launch of Crysvita® in Japan CRYSVITA is first in class medicine for X-linked hypophosphataemia that targets the underlying cause of FGF23-related hypophosphatemic rickets and osteomalacia. kyowakirin.com ↗
2019-11-05	Kyowa Kirin, Inc.	European Medicines Agency Accepts Kyowa Kirin’s Application for the Expanded Use of CRYSVITA® (burosumab) for the Treatment of Adults with X-Linked Hypophosphataemia kyowakirin.com ↗
2019-09-30	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce U.S. FDA Approves Label Update for Crysvita® (burosumab) for the Treatment of X-Linked Hypophosphatemia (XLH) Expanded Label Includes Additional Clinical Data Highlighting Superiority Over Conventional Therapy for Pediatric Patients and Extends Current U.S. Indication to Patients Aged Six Months and Older Expanded Label Includes Data Demonstrating Improvement in Stiffness, Continued Further Healing of Fractures and Maintenance of Efficacy with Longer-Term Treatment in Adults kyowakirin.com ↗
2019-09-30	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce U.S. FDA Approves Label Update for Crysvita® (burosumab) for the Treatment of X-Linked Hypophosphatemia (XLH) ultragenyx.com ↗
2019-09-20	Kyowa Kirin, Inc.	Kyowa Kirin Announces Approval of Crysvita® (burosumab) for the Treatment of FGF23-related Hypophosphatemic Rickets and Osteomalacia in Japan kyowakirin.com ↗
2019-09-10	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce Intent to Submit Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) in Tumor-Induced Osteomalacia (TIO) kyowakirin.com ↗
2019-09-10	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce Intent to Submit Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) in Tumor-Induced Osteomalacia (TIO) ultragenyx.com ↗
2019-03-26	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces Approval of Crysvita® (burosumab) in Brazil for the Treatment of X-linked Hypophosphatemia (XLH) in Adults and Children ultragenyx.com ↗
2019-02-15	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce Positive 64-Week Results for Crysvita® (burosumab) from Phase 3 Study in Children with X-linked Hypophosphatemia (XLH) Results Confirm and Extend 40-Week Findings that Treatment with Crysvita is Superior to Conventional Therapy kyowakirin.com ↗
2019-02-14	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce Positive 64-Week Results for Crysvita® (burosumab) from Phase 3 Study in Children with X-linked Hypophosphatemia (XLH) ultragenyx.com ↗
2019-01-07	Kyowa Kirin, Inc.	Kyowa Hakko Kirin Submits Application for Approval of Burosumab for FGF23-related Hypophosphatemic Rickets and Osteomalacia in Japan kyowakirin.com ↗
2018-12-06	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce Health Canada Approval of Crysvita™ (burosumab injection) for the Treatment of X-linked Hypophosphatemia (XLH) in Adults and Children First Approved Treatment for XLH in Canada that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease kyowakirin.com ↗
2018-12-06	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce Health Canada Approval of Crysvita™ (burosumab injection) for the Treatment of X–linked Hypophosphatemia (XLH) in Adults and Children ultragenyx.com ↗
2018-05-24	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce Publication of Phase 2 Study Results Demonstrating that Crysvita® (burosumab) Improved Outcomes in Children with X-linked Hypophosphatemia in the New England Journal of MedicinePediatric Study Demonstrated Improvements in Rickets Severity, Growth, Pain and Physical Activity in Children with Debilitating, Lifelong Hereditary Disease kyowakirin.com ↗
2018-05-23	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce Publication of Phase 2 Study Results Demonstrating that Crysvita® (burosumab) Improved Outcomes in Children with X-linked Hypophosphatemia in the New England Journal of Medicine ultragenyx.com ↗
2018-05-17	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce Topline Phase 3 Study Results Demonstrating Superiority of Crysvita® (burosumab) Treatment to Oral Phosphate and Active Vitamin D in Children with X-Linked Hypophosphatemia (XLH)Substantial Healing of Rickets Observed in 72% of Patients Treated with Crysvita Comparedto 6% of Patients Receiving Conventional Therapy at 40 Weeks kyowakirin.com ↗
2018-05-17	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce Topline Phase 3 Study Results Demonstrating Superiority of Crysvita® (burosumab) Treatment to Oral Phosphate and Active Vitamin D in Children with X-Linked Hypophosphatemia (XLH) ultragenyx.com ↗
2018-05-07	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce Crysvita®(burosumab-twza) Now Launched in the U.S. for the Treatment of X–linked Hypophosphatemia (XLH) in Children and AdultsFirst FDA-Approved Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong DiseaseUltraCare™ Program in Place to Provide Ongoing Patient Support kyowakirin.com ↗
2018-04-30	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce Crysvita® (burosumab-twza) Now Launched in the U.S. for the Treatment of X–linked Hypophosphatemia (XLH) in Children and Adults ultragenyx.com ↗
2018-04-18	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita®(burosumab-twza) for the Treatment of Children and Adults with X–Linked Hypophosphatemia (XLH)First Approved Therapy for XLH in the U.S.; Only Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease kyowakirin.com ↗
2018-04-17	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita® (burosumab-twza) for the Treatment of Children and Adults with X–Linked Hypophosphatemia (XLH) ultragenyx.com ↗
2018-02-23	Kyowa Kirin, Inc.	Kyowa Kirin and Ultragenyx Announce Crysvita® (burosumab) Receives Conditional Marketing Authorisation in Europe for the Treatment of X–Linked Hypophosphatemia in ChildrenCrysvita is the First Treatment for XLH that Targets the Underlying Cause of the DiseaseCrysvita Acknowledged by European Medicines Agency as anOutstanding Contribution to Public Health kyowakirin.com ↗
2018-02-23	Ultragenyx Pharmaceutical Inc	Kyowa Kirin and Ultragenyx Announce Crysvita® (burosumab) Receives Conditional Marketing Authorization in Europe for the Treatment of X–Linked Hypophosphatemia in Children ultragenyx.com ↗
2017-12-15	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce Burosumab Receives Positive CHMP Opinion for the Treatment of X-Linked Hypophosphatemia in ChildrenIf approved, Burosumab would be the first targeted disease-modifying treatment for XLH kyowakirin.com ↗
2017-12-15	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce Burosumab Receives Positive CHMP Opinion for the Treatment of X-Linked Hypophosphatemia in Children ultragenyx.com ↗
2017-12-04	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin Announce Positive 48-Week Data from Adult Phase 3 Study of Burosumab (KRN23) in X-Linked HypophosphatemiaFurther improvement in disease symptoms and fracture healing observed through 48 weeks of treatment with burosumab kyowakirin.com ↗
2017-12-04	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin Announce Positive 48-Week Data from Adult Phase 3 Study of Burosumab (KRN23) in X-Linked Hypophosphatemia ultragenyx.com ↗
2017-11-01	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Hakko Kirin Announce FDA Not Currently Planning to Hold Advisory Committee Meeting for Burosumab Biologics License ApplicationRegulatory Review Process Proceeding as Expected; PDUFA date of April 17, 2018 kyowakirin.com ↗
2017-11-01	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Hakko Kirin Announce FDA Not Currently Planning to Hold Advisory Committee Meeting for Burosumab Biologics License Application ultragenyx.com ↗
2017-10-10	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab's Biologics License Application kyowakirin.com ↗
2017-10-10	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab's Biologics License Application ultragenyx.com ↗
2017-09-12	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Hakko Kirin Announce Additional Burosumab Data in X-Linked Hypophosphatemia (XLH) and Tumor-Induced Osteomalacia (TIO) at ASBMRPositive data in bone disease in pediatric XLH patients under 5 years old and in TIO patients kyowakirin.com ↗
2017-09-11	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Hakko Kirin Announce Additional Burosumab Data in X-Linked Hypophosphatemia (XLH) and Tumor-Induced Osteomalacia (TIO) at ASBMR ultragenyx.com ↗
2017-08-24	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Hakko Kirin Announce Submission of Burosumab's Biologics License Application in the US kyowakirin.com ↗
2017-08-24	Kyowa Kirin, Inc.	Kyowa Hakko Kirin and Kyowa Kirin International Announce Burosumab Data Presentations at ASBMR 2017 Annual Meeting kyowakirin.com ↗
2017-08-24	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces Burosumab Data Presentations at ASBMR 2017 Annual Meeting ultragenyx.com ↗
2017-08-24	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Hakko Kirin Announce Submission of Burosumab's Biologics License Application in the US ultragenyx.com ↗
2017-07-28	Kyowa Kirin, Inc.	Kyowa Hakko Kirin and Kyowa Kirin International Announce Regulatory Updates for Burosumab in the US and EU. kyowakirin.com ↗
2017-06-23	Ultragenyx Pharmaceutical Inc	Ultragenyx Provides Regulatory Update on Burosumab (KRN23) ultragenyx.com ↗
2017-04-19	Kyowa Kirin, Inc.	Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International Announce Positive 24-Week Data from Adult Phase 3 Study of Burosumab (KRN23) in X-Linked HypophosphatemiaStudy met primary endpoint of serum phosphorus response and key secondary endpoint of stiffness improvementUltragenyx to host conference call today at 4:30pm ET to discuss results kyowakirin.com ↗
2017-04-18	Ultragenyx Pharmaceutical Inc	Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International Announce Positive 24-Week Data from Adult Phase 3 Study of Burosumab (KRN23) in X-Linked Hypophosphatemia ultragenyx.com ↗
2017-04-06	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin International Announce Positive Data from Paediatric Phase 2 Studies of Burosumab (KRN23) in X-Linked HypophosphatemiaSustained reduction in bone disease and improvement in growth through 64 weeks of treatment and sustained effect on bone mineral metabolites in patients under 5 years old kyowakirin.com ↗
2017-04-06	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin International Announce Positive Data from Pediatric Phase 2 Studies of Burosumab (KRN23) in X-Linked Hypophosphatemia ultragenyx.com ↗
2017-01-05	Kyowa Kirin, Inc.	Ultragenyx and Kyowa Kirin International Announce Marketing Authorisation Application for KRN23 Filed and Accepted for Review by European Medicines Agency kyowakirin.com ↗
2017-01-05	Ultragenyx Pharmaceutical Inc	Ultragenyx and Kyowa Kirin International Announce Marketing Authorization Application for KRN23 Filed and Accepted for Review by European Medicines Agency ultragenyx.com ↗
2016-10-26	Kyowa Kirin, Inc.	Kyowa Hakko Kirin Announces First Patient Enrolled Global Phase 3 Study of KRN23 in Pediatric Patients with X-Linked Hypophosphatemia (XLH) kyowakirin.com ↗
2016-10-26	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces First Patient Enrolled in Global Phase 3 Study of KRN23 in Pediatric Patients with X-Linked Hypophosphatemia (XLH) ultragenyx.com ↗
2016-09-20	Kyowa Kirin, Inc.	Kyowa Hakko Kirin Announces Positive Interim Data from Pediatric and Adult Phase 2 Studies of KRN23 in X-Linked HypophosphatemiaPediatric study demonstrates substantial reduction in bone disease and improvement in growth rates Adult study demonstrates increase in serum phosphorus and provides evidence of clinical improvement kyowakirin.com ↗
2016-09-20	Kyowa Kirin, Inc.	Kyowa Hakko Kirin Announces Positive Interim Data from Phase 2 Study of KRN23 for the Treatment of Tumor-Induced Osteomalacia kyowakirin.com ↗
2016-09-19	Ultragenyx Pharmaceutical Inc	Ultragenyx Reports Positive Interim Data from Pediatric and Adult Phase 2 Studies of KRN23 in X-Linked Hypophosphatemia ultragenyx.com ↗
2016-09-18	Ultragenyx Pharmaceutical Inc	Ultragenyx Reports Positive Interim Data from Phase 2 Study of KRN23 for the Treatment of Tumor-Induced Osteomalacia ultragenyx.com ↗
2016-09-16	Ultragenyx Pharmaceutical Inc	Ultragenyx to Host Conference Call to Discuss KRN23 Data Presented at ASBMR 2016 Annual Meeting ultragenyx.com ↗
2016-08-23	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces KRN23 Data Presentations at ASBMR 2016 Annual Meeting ultragenyx.com ↗
2016-07-28	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces Completion of Enrollment in Phase 3 Study of KRN23 in Adults with X-Linked Hypophosphatemia (XLH) ultragenyx.com ↗
2016-06-28	Kyowa Kirin, Inc.	US Food and Drug Administration Granted Breakthrough Therapy Designation for KRN23 for Pediatric X-Linked Hypophosphatemia kyowakirin.com ↗
2016-06-28	Ultragenyx Pharmaceutical Inc	Ultragenyx Receives Breakthrough Therapy Designation for KRN23 in Pediatric Patients with X-Linked Hypophosphatemia ultragenyx.com ↗
2016-04-21	Kyowa Kirin, Inc.	Kyowa Hakko Kirin Announces Positive Interim Data from Phase 2 Study of KRN23 for the Treatment of Tumor-Induced Osteomalacia kyowakirin.com ↗
2016-04-21	Ultragenyx Pharmaceutical Inc	Ultragenyx Reports Positive Interim Data from Phase 2 Study of KRN23 for the Treatment of Tumor-Induced Osteomalacia ultragenyx.com ↗
2015-12-03	Kyowa Kirin, Inc.	Kyowa Hakko Kirin Announces Initiation of Global Phase 3 Study of KRN23 in Adults with X-Linked Hypophosphatemia (XLH) kyowakirin.com ↗
2015-12-03	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces First Patient Enrolled in Global Phase 3 Study of KRN23 in Adults With X-Linked Hypophosphatemia (XLH) ultragenyx.com ↗
2015-12-02	Kyowa Kirin, Inc.	Kyowa Hakko Kirin Announces Positive Interim 40-Week Data from Pediatric Phase 2 Study of KRN23 in X-Linked HypophosphatemiaSubstantial reduction in bone disease demonstrated with two different instruments kyowakirin.com ↗
2015-12-02	Ultragenyx Pharmaceutical Inc	Ultragenyx Reports Positive Interim 40-Week Data From Pediatric Phase 2 Study of KRN23 in X-Linked Hypophosphatemia ultragenyx.com ↗
2015-07-09	Ultragenyx Pharmaceutical Inc	Ultragenyx Releases Positive Interim 40-Week Bone Treatment Data From Ongoing Pediatric Phase 2 Study of KRN23 in X-Linked Hypophosphatemia ultragenyx.com ↗
2015-06-02	Ultragenyx Pharmaceutical Inc	Ultragenyx Releases Positive 16-Week Interim Data From Pediatric Phase 2 Study of KRN23 in X-Linked Hypophosphatemia ultragenyx.com ↗
2015-01-06	Ultragenyx Pharmaceutical Inc	Ultragenyx Initiates New Development Program Studying KRN23 for the Treatment of Tumor-Induced Osteomalacia ultragenyx.com ↗
2014-10-30	Ultragenyx Pharmaceutical Inc	Ultragenyx Granted EU Orphan Drug Designation for KRN23 for the Treatment of X-Linked Hypophosphatemia ultragenyx.com ↗
2014-09-16	Kyowa Kirin, Inc.	Announcement of Results from Long-Term Phase 1/2 Study of KRN23 in X-linked Hypophosphatemia in Adults kyowakirin.com ↗
2014-09-15	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces Positive Results From a Long-Term Phase 1/2 Study of KRN23 in Adult Patients With X-Linked Hypophosphatemia ultragenyx.com ↗
2014-07-29	Kyowa Kirin, Inc.	Announcement of Start of Phase 1 Joint Japanese-Korean Study of a Human Monoclonal Anti-FGF23 Antibody (KRN23) in X-linked Hypophosphatemic Rickets/Osteomalacia in Adults kyowakirin.com ↗
2014-07-24	Kyowa Kirin, Inc.	Kyowa Hakko Kirin Announces Initiation of a Phase 2 Study of KRN23 for Pediatric X-Linked Hypophosphatemic Rickets in the US and EU kyowakirin.com ↗
2014-07-01	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces Initiation of a Phase 2 Study of KRN23 for Pediatric X-Linked Hypophosphatemia in the US and EU ultragenyx.com ↗
2014-06-25	Kyowa Kirin, Inc.	Announcement of Results from a Multiple Dose Phase 1/2 Study of a Human Monoclonal Anti-FGF23 Antibody (KRN23) in X-linked Hypophosphatemia in Adults kyowakirin.com ↗
2014-06-24	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces Results From Phase 1/2 Study of KRN23 in X-linked Hypophosphatemia in Adults ultragenyx.com ↗
2014-05-19	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces KRN23 Phase 1/2 Study Data to be Presented at ICE/ENDO Meeting on June 23rd and June 24th ultragenyx.com ↗
2013-10-07	Kyowa Kirin, Inc.	Announcement of Results from a Single Dose Phase 1 Study of a Human Monoclonal Anti-FGF23 Antibody (KRN23) in X-linked Hypophosphatemia in Adults kyowakirin.com ↗
2013-10-06	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces the Presentation of Data from a Single Dose Phase 1 Study, Conducted by Kyowa Hakko Kirin Co. Ltd. (KHK), of KRN23 in X-linked Hypophosphatemia (XLH) in Adults ultragenyx.com ↗
2013-09-04	Kyowa Kirin, Inc.	Collaboration with Ultragenyx to Develop and Commercialize KRN23 for X-linked Hypophosphatemia kyowakirin.com ↗
2013-09-03	Ultragenyx Pharmaceutical Inc	Ultragenyx Announces Collaboration with Kyowa Hakko Kirin to Develop and Commercialize Phase 2-stage KRN23 for X-linked Hypophosphatemia ultragenyx.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

Field	Value	Cited text
Known as	burosumab	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02163577 ↗ 14 NCT03993821 ↗ NCT04695860 ↗ NCT02915705 ↗ NCT02537431 ↗ NCT04419363 ↗ NCT03581591 ↗ NCT04146935 ↗ NCT02526160 ↗ NCT02750618 ↗ NCT04188964 ↗ Show 4 more sources
Known as	burosumab-twza	ClinicalTrials.gov intervention name — accepted as the source's own label NCT04320316 ↗
Known as	Crysvita	“Crysvita (burosumab-twza) Treatment” NCT04320316 ↗
Known as	KRN23	“Burosumab (KRN23), is an IgG1 monoclonal antibody that binds to the FGF23 receptor and inhibits the activity of FGF23.” PMID 35899095 ↗ Jul 2022 12 “Anti- FGF23 Antibody Burosumab (KRN23) in Adult Patients” NCT04695860 ↗ NCT04842019 ↗ NCT00830674 ↗ NCT01571596 ↗ NCT04842032 ↗ NCT02312687 ↗ NCT03233126 ↗ NCT04308096 ↗ NCT02722798 ↗ NCT05357573 ↗ Show 2 more sources
Action	Inhibit	“blocks its activity” PMID 26073451 ↗ Aug 2015
Modality	Monoclonal antibody	“KRN23 is a recombinant human IgG1 monoclonal antibody” PMID 26073451 ↗ Aug 2015
Route	Intravenous	“Single IV administration on day 1” NCT00830674 ↗
Target	FGF23	“human anti-FGF23 antibody” PMID 24569459 ↗ Feb 2014