Emicizumab

also known as Hemlibra · ACE910 · Emicizumab kxwh · HEMLIBRA- emicizumab injection, solution

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed hemophilia A with vascular abnormality 2 milestones
Filed	US (FDA)	HEMLIBRA	hemophilia A with vascular abnormality	2018-06-04	“FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for HEMLIBRA® (emicizumab-kxwh) for adults and children” gene.com ↗
Filed	EU (EMA)	—	hemophilia A with vascular abnormality	—	“Outside the US, emicizumab has been filed in the EU in June 2017” chugai-pharm.co.jp ↗
Filed hemophilia B leyden 4 milestones
Filed	US (FDA)	Hemlibra	hemophilia B leyden	2018-06-05	“today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA)” roche.com ↗
Filed	US (FDA)	—	hemophilia B leyden	2017-08-23	“the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA)” gene.com ↗ “the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA)” roche.com ↗ “the US Food and Drugs Administration (FDA) has accepted the Biologics License Application (BLA)” chugai-pharm.co.jp ↗
Filed	EU (EMA)	Hemlibra	hemophilia B leyden	—	“the company's Marketing Authorisation Application (MAA) variation of Hemlibra for haemophilia A without factor VIII inhibitors is under review by the European Medicines Agency (EMA).” roche.com ↗ “An EU marketing authorization application was submitted in June 2017” chugai-pharm.co.jp ↗ “Outside US, emicizumab has been filed in the EU in June 2017” chugai-pharm.co.jp ↗
Filed	Japan (PMDA)	Hemlibra	hemophilia B leyden	—	“An application for an additional indication of the treatment of hemophilia A without factor VIII inhibitors has been filed in April in Japan.” chugai-pharm.co.jp ↗
Approved Indication not stated 3 milestones
Label expansion	US (FDA)	HEMLIBRA	—	2018-10-04	fda.gov ↗
Approved	EU (EMA)	Hemlibra	—	2018-02-23	europa.eu ↗
Approved	US (FDA)	HEMLIBRA	—	2017-11-16	fda.gov ↗

Trials 26

today

US approved 2017

EU approved 2018

NCT06998524 · Ph 3 NCT06938659 · Ph 2/3 NCT07439055 · Ph 2/3 NCT06155955 · Ph 2/3 NCT05500807 · Ph 1 NCT05345197 · Ph 2 NCT04567511 · Ph 4 NCT05181618 · Ph 4 NCT04030052 · Ph 3 NCT04303572 · Ph 3 NCT04303559 · Ph 3 NCT05279924 · not/applicable NCT04188639 · Ph 2 NCT04431726 · Ph 3 NCT02196207 · Ph 3 NCT04158648 · Ph 3 NCT03921294 · Ph 4 NCT03361137 · Ph 4 NCT03315455 · Ph 3 NCT03380780 · Ph 1 NCT03191799 · Ph 3 NCT03020160 · Ph 3 NCT02847637 · Ph 3 NCT02795767 · Ph 3 NCT02622321 · Ph 3

201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 12 trials
Phase 1	NCT05500807	Nov 2022 → Jun 2027 expected	von Willebrand disease 3	Bleeding and Clotting Disorders Institute Peoria, Illinois	Recruiting	No outcome recorded
Phase 1	NCT03380780	Mar → Sep 2018	hemophilia A	Hoffmann-La Roche	Completed	No outcome recorded
Phase 22 trials
Phase 2	NCT05345197	Aug 2022 → Jul 2026 overdue	acquired hemophilia A	University of Washington	Active not recruiting	No outcome recorded
Phase 2	NCT04188639	Mar 2021 → Jan 2023	acquired hemophilia A	GWT-TUD GmbH	Completed	No outcome recorded
Phase 2/33 trials
Phase 2/3	NCT06938659	Jun 2025 → May 2026 overdue	hemophilia A	Dhaka Medical College	Not yet recruiting	No outcome recorded
Phase 2/3	NCT07439055	Jun 2025 → Mar 2026 overdue	hemophilia A	Chulalongkorn University	Active not recruiting	No outcome recorded
Phase 2/3	NCT06155955	Jun 2023 → Mar 2024	hemarthrosis, severe hemophilia A	Chulalongkorn University	Unknown	No outcome recorded
Phase 313 trials · 5 met primary
Phase 3	NCT06998524	Jun 2025 → Apr 2027 expected	von Willebrand disease 3	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 3	NCT04030052	Feb 2022 → Jan 2023	hemophilia A	Emory University	Withdrawn	No outcome recorded Stop: Enrollment
Phase 3	NCT04303572	Nov 2021 → Jun 2022	severe hemophilia A	Margaret Ragni	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT04303559	Oct 2021 → Apr 2022	hemophilia A	Margaret Ragni	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT04431726	Feb 2021 → May 2023 overdue	severe hemophilia A	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 3	NCT02196207	Aug 2020 → Jul 2027	severe hemophilia A	Margaret Ragni	Withdrawn	No outcome recorded
Phase 3	NCT04158648	Feb 2020 → Oct 2021	mild hemophilia A, moderately severe hemophilia A	Hoffmann-La Roche	Completed	No outcome recorded
Phase 3	NCT03315455	Apr 2018 → Aug 2022	hemophilia A	Hoffmann-La Roche	Completed	Met primary
Phase 3	NCT03191799	Sep 2017 → Nov 2020	hemophilia A	Hoffmann-La Roche	Completed	No outcome recorded
Phase 3	NCT03020160	Jan → Dec 2017	hemophilia A	Hoffmann-La Roche	Completed	Met primary
Phase 3	NCT02847637	Sep 2016 → Sep 2017	hemophilia A	Hoffmann-La Roche	Completed	Met primary
Phase 3	NCT02795767	Jul 2016 → Apr 2018	hemophilia A	Hoffmann-La Roche	Completed	Met primary
Phase 3	NCT02622321	Nov 2015 → Oct 2016	hemophilia A	Hoffmann-La Roche	Completed	Met primary

Phase 44 trials
Phase 4	NCT04567511	Jul 2022 → Jul 2025 overdue	hemophilia A	Indiana Hemophilia &Thrombosis Center, Inc.	Recruiting	No outcome recorded
Phase 4	NCT05181618	Jun 2022 → Dec 2026 expected	moderately severe hemophilia A, severe hemophilia A	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 4	NCT03921294	May 2019 → Mar 2022	hemophilia A with vascular abnormality	Indiana Hemophilia &Thrombosis Center, Inc.	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT03361137	Jun 2018 → Mar 2020	hemophilia A	Genentech, Inc.	Terminated	No outcome recorded Stop: Enrollment
Phase not applicable1 trial
—	NCT05279924	Jul 2021 → Oct 2022	hemophilia A	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Completed	No outcome recorded
Phase not stated1 trial
—	NCT03154437	—	hemophilia A	Genentech, Inc.	Approved for marketing	No outcome recorded
Comparator or background therapy6 trials
Phase 3	NCT04563520 Background	Jun 2026 → Mar 2027 expected	hemophilia A	Emory University	Recruiting	No outcome recorded
Phase 3	NCT07416604 Comparator	Apr 2026 → Feb 2028 expected	hemophilia A	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 4	NCT07158606 Background	Oct 2025 → Dec 2030 expected	hemophilia A	Versiti Blood Health	Not yet recruiting	No outcome recorded
Phase 4	NCT06145373 Background	Mar 2024 → May 2028 expected	hemophilia A	Sanofi	Recruiting	No outcome recorded
Phase 4	NCT04690322 Comparator	Apr 2021 → Jul 2027	hemophilia A	University of Texas Southwestern Medical Center	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT04621916 Comparator	Sep 2020 → Sep 2024	hemophilia A	Children's Hospital Los Angeles	Unknown	No outcome recorded

News releases announcing trial results or a regulatory action · 108

Date	Issuer	Release
2026-03-04	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Regulatory VOLUNTARY ANNOUNCEMENT - EMICIZUMAB INJECTION (SYS6053) OBTAINS CLINICAL TRIAL APPROVAL IN CHINA irasia.com ↗ EMICIZUMAB INJECTION (SYS6053) OBTAINS CLINICAL TRIAL APPROVAL IN CHINA
2025-11-03	Hoffmann-La Roche	Results Roche to present new data from its broad and innovative haematology portfolio at ASH 2025 roche.com ↗ These findings add to the wealth of clinical and real-world evidence in support of Hemlibra as it continues to redefine standards of care for people living with haemophilia A.
2025-11-03	Genentech, Inc.	Results Genentech to Present New Data From Its Broad and Innovative Hematology Portfolio at ASH 2025 gene.com ↗ New post-marketing data from the Beyond ABR study show that, in the first year after switching to Hemlibra prophylaxis from factor VIII prophylaxis, people with various levels of baseline joint impairment had low bleeding rates, associated with overall improvements in joint health, and a shift towards higher activity levels.
2023-12-11	Chugai Pharmaceutical	Results New Data Reinforce the Benefit of Early Preventative Treatment with Chugai’s Hemlibra for Babies with Severe Hemophilia A chugai-pharm.co.jp ↗ Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age, and was well tolerated.
2023-12-09	Hoffmann-La Roche	Results New data reinforce the benefit of early preventative treatment with Roche’s Hemlibra for babies with severe haemophilia A roche.com ↗ Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age, and was well tolerated.
2023-12-09	Genentech, Inc.	Results New Data Reinforce the Benefit of Early Preventative Treatment With Genentech’s Hemlibra (emicizumab-kxwh) for Babies With Severe Hemophilia A gene.com ↗ Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age and was well tolerated.
2023-06-26	Chugai Pharmaceutical	Results New Data from the Japanese Phase III Clinical Trial of Hemlibra for Acquired Hemophilia A (AGEHA Study) Presented at ISTH chugai-pharm.co.jp ↗ The newly presented data of Hemlibra suggest sustained bleeding control within long-term administration and reduced risk of bleeding in patients who are ineligible for immunosuppressive therapy, which is the standard of care.
2023-02-01	Hoffmann-La Roche	Regulatory European Commission approves label expansion of Roche’s Hemlibra to include people with moderate haemophilia A in the EU roche.com ↗ Basel, 01 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission approved the expansion of the Hemlibra® (emicizumab) European Union (EU) marketing authorisation.
2023-02-01	Chugai Pharmaceutical	Regulatory Chugai’s Hemlibra Approved by the European Commission to Treat People with Moderate Hemophilia A chugai-pharm.co.jp ↗ TOKYO, February 1, 2023 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Roche has received notification that the European Commission has extended the marketing authorization for the anti-coagulation factor IXa/X humanized bispecific monoclonal antibody/coagulation factor VIII substitute Hemlibra ® [generic name: emicizumab (genetical recombination)] to include routine prophylaxis of bleeding episodes in people with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, who have moderate disease (FVIII ≥1% and ≤ 5%) with a severe bleeding phenotype.
2022-12-19	Chugai Pharmaceutical	Regulatory CHMP Recommends Expansion of EU Label for Hemlibra to Include People with Moderate Hemophilia A chugai-pharm.co.jp ↗ The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended to approve the additional indication of Hemlibra for moderate hemophilia A.
2022-12-16	Hoffmann-La Roche	Regulatory CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A roche.com ↗ Basel, 16 December 2022 - Roche (SIX: RO, ROG; OTCQZ: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expansion of the Hemlibra® (emicizumab) European Union (EU) marketing authorisation.
2022-12-12	Chugai Pharmaceutical	Results Roche Presents Data at American Society of Hematology (ASH) Annual Meeting chugai-pharm.co.jp ↗ Interim data from phase III study presented at ASH 2022 show Hemlibra achieved meaningful bleed control in infants from birth
2022-12-11	Hoffmann-La Roche	Results Interim data from phase III study presented at ASH 2022 show Hemlibra achieved meaningful bleed control in infants from birth roche.com ↗ In the study, 77.8% of participants had no bleeding episodes that required treatment
2022-12-10	Genentech, Inc.	Results Interim Data From Phase III Study Presented at ASH 2022 Show Hemlibra (emicizumab-kxwh) Achieved Meaningful Bleed Control in Infants From Birth gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced interim results from the Phase III HAVEN 7 study.
2022-11-03	Hoffmann-La Roche	Results Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs roche.com ↗ Interim data from the phase III HAVEN 7 study reinforce the efficacy and safety of Hemlibra® (emicizumab) in infants with severe haemophilia A without factor VIII inhibitors.1
2022-11-03	Genentech, Inc.	Results Genentech to Present Data at ASH 2022 Showcasing Strength of Hematology Portfolio and Expanding Into New Areas to Address More Patient Needs gene.com ↗ Interim data from Phase III HAVEN 7 study reinforce Hemlibra’s efficacy and safety in infants with severe hemophilia A without factor VIII inhibitors
2022-07-12	Chugai Pharmaceutical	Results Primary Analysis of Japanese Phase III Clinical Trial of Hemlibra for Acquired Hemophilia A (AGEHA Study) Presented at ISTH chugai-pharm.co.jp ↗ Data from AGEHA Study suggested a favorable benefit-risk profile of Hemlibra in acquired hemophilia A under a dosing regimen and completion criteria determined specifically for the disease
2022-07-12	Chugai Pharmaceutical	Results New Data from Phase III HAVEN 6 Study Reinforce Favorable Safety and Efficacy Profile of Chugai’s Hemlibra in People with Moderate or Mild Hemophilia A chugai-pharm.co.jp ↗ Hemlibra continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mild hemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up
2022-07-11	Hoffmann-La Roche	Results New data from phase III HAVEN 6 study reinforce favourable safety and efficacy profile of Roche’s Hemlibra in people with moderate or mild haemophilia A roche.com ↗ Hemlibra continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mild haemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up [1]
2022-07-11	Genentech, Inc.	Results New Data From Phase III Haven 6 Study Reinforce Favorable Safety and Efficacy Profile of Genentech’s Hemlibra (emicizumab-kxwh) in People with Moderate or Mild Hemophilia A gene.com ↗ Hemlibra continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mild hemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up
2022-06-20	Chugai Pharmaceutical	Regulatory Chugai Obtains Regulatory Approval for Hemlibra for Additional Indication of Acquired Hemophilia A chugai-pharm.co.jp ↗
2021-12-13	Hoffmann-La Roche	Results Interim data from phase III HAVEN 6 study demonstrate favourable safety and efficacy profile of Roche’s Hemlibra in people with moderate or mild haemophilia A roche.com ↗ Hemlibra also achieved clinically meaningful bleed control, with 80.3% of participants experiencing no bleeding episodes that required treatment and 90.1% experiencing no joint bleeds that required treatment
2021-12-13	Chugai Pharmaceutical	Results Interim Data from Phase III HAVEN 6 Study Demonstrate Safety and Efficacy Profile of Chugai’s Hemlibra in People with Moderate or Mild Hemophilia A chugai-pharm.co.jp ↗ New data demonstrates Hemlibra’s safety profile in people with moderate or mild hemophilia A without factor VIII inhibitors, with no new safety signals identified
2021-12-12	Genentech, Inc.	Results Interim Data From Phase III HAVEN 6 Study Demonstrate Favorable Safety and Efficacy Profile of Genentech’s Hemlibra (emicizumab-kxwh) in People With Moderate or Mild Hemophilia A gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from an interim analysis of the Phase III HAVEN 6 study, which show Hemlibra® (emicizumab-kxwh) demonstrated a favorable safety profile and effective bleed control in people with moderate or mild hemophilia A without factor VIII inhibitors.
2021-11-23	Hoffmann-La Roche	Results Roche to present new pivotal data at ASH 2021 from broad and comprehensive portfolio, challenging treatment standards for people with blood disorders roche.com ↗ HAVEN 6 phase III interim data demonstrated Hemlibra’s favourable safety and efficacy profile in people with moderate or mild haemophilia A3
2021-11-23	Genentech, Inc.	Results Genentech to Present New Pivotal Data at ASH 2021 From Broad and Comprehensive Portfolio, Challenging Treatment Standards for People With Blood Disorders gene.com ↗ Interim data from the Phase III HAVEN 6 study, which demonstrated the favorable safety and efficacy profile of Hemlibra® (emicizumab-kxwh) in people with moderate or mild hemophilia A without factor VIII inhibitors.
2021-11-11	Chugai Pharmaceutical	Regulatory Chugai Files for Additional Indication of Hemlibra for Treatment of Acquired Hemophilia A chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it filed an application today with the Ministry of Health, Labour and Welfare (MHLW) for approval of additional indication for the anti-coagulation factor IXa/X humanized bispecific monoclonal antibody / coagulation factor VIII substitute Hemlibra ® [generic name: emicizumab (genetical recombination)] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people with acquired blood coagulation factor VIII deficiency.
2021-10-01	Chugai Pharmaceutical	Regulatory Chugai Receives Orphan Drug Designation for Hemlibra in Acquired Hemophilia A chugai-pharm.co.jp ↗
2021-07-19	Hoffmann-La Roche	Results New data for Roche’s Hemlibra reinforce safety profile in people with haemophilia A roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the final analysis of the phase IIIb STASEY study, which confirm the favourable safety profile of Hemlibra® (emicizumab), consistent with the phase III HAVEN clinical programme.
2021-07-18	Genentech, Inc.	Results New Data for Genentech’s Hemlibra (emicizumab-kxwh) Reinforce Safety Profile in People With Hemophilia A gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the final analysis of the Phase IIIb STASEY study, which confirm the favorable safety profile of Hemlibra® (emicizumab-kxwh), consistent with the Phase III HAVEN clinical program.
2021-07-02	Hoffmann-La Roche	Results Roche to present new data at the ISTH 2021 Congress highlighting long-standing commitment to advancing haemophilia A standard of care roche.com ↗ Roche will present the final analysis from the phase IIIb STASEY study, reinforcing the safety and efficacy profile of Hemlibra in a broad range of people with haemophilia A with factor VIII inhibitors1
2021-03-26	Sobi, Inc.	Results Evaluation of haemophilia A treatment options shows favourable efficacy results for Elocta® sobi.com ↗ The publication reported in an indirect comparison that individualised prophylaxis with Elocta® (rFVIIIFc-efmoroctog alfa) is more efficacious than Hemlibra™ (emicizumab) administered every four weeks, and at least as effective as more frequent emicizumab regimens for the management of haemophilia A.
2021-02-03	Takeda	Results Data at EAHAD 2021 Highlight Value of Takeda’s Leading Hematology Portfolio in Clinical Settings and Commitment to Patient-Focused Advancements takeda.com ↗ Results showed that there were no statistically significant differences in prophylactic effectiveness between treatments.
2020-12-07	Hoffmann-La Roche	Results New follow-up phase III data reinforce the long-term benefit of Roche’s Hemlibra for people with haemophilia A roche.com ↗ With nearly three years of follow-up, Hemlibra maintained low treated bleed rates and was well tolerated in people with haemophilia A of all ages, with and without factor VIII inhibitors
2020-11-05	Hoffmann-La Roche	Results Roche to present new data across 16 blood disorders at the American Society of Hematology 2020 Annual Meeting roche.com ↗ Three year follow-up data from the pivotal phase III HAVEN study programme (HAVEN 1-4 studies), reinforcing the efficacy and safety profile of Hemlibra® (emicizumab) in people with haemophilia A with and without factor VIII inhibitors.
2020-11-05	Genentech, Inc.	Results Genentech to Present New Data Across 16 Blood Disorders at the American Society of Hematology 2020 Annual Meeting gene.com ↗ Three-year follow-up data from the pivotal Phase III HAVEN study program (HAVEN 1-4 studies), reinforcing the efficacy and safety profile of Hemlibra ® (emicizumab-kxwh) in people with hemophilia A with and without factor VIII inhibitors.
2020-07-13	Hoffmann-La Roche	Results New data from phase IIIb study reinforces safety profile of Roche’s Hemlibra in people with haemophilia A roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the second interim analysis of the phase IIIb STASEY study, which reinforce the safety profile of Hemlibra® (emicizumab) characterised in the phase III HAVEN clinical programme.
2020-07-13	Chugai Pharmaceutical	Results New Interim Results from Phase IIIb Study Reinforce the Long-Term Safety Profile of Chugai’s Hemlibra in Hemophilia A chugai-pharm.co.jp ↗ The second interim analysis of the STASEY study, including data from 193 people with hemophilia A, was consistent with the results from phase III HAVEN studies, with no new safety signals identified 1,2,3 .
2020-07-12	Genentech, Inc.	Results New Data From Phase IIIb Study Reinforces Safety Profile of Genentech’s Hemlibra (emicizumab-kxwh) in People With Hemophilia A gene.com ↗ In the STASEY study, Hemlibra was effective with no new safety signals identified in adults and adolescents with hemophilia A with factor VIII inhibitors, which was consistent with previous safety observations.
2020-06-29	Hoffmann-La Roche	Results Roche announces new data at the ISTH 2020 Congress, demonstrating ongoing commitment to advancing care for people with haemophilia A roche.com ↗ Roche will present second interim analysis results from the phase IIIb STASEY study, reinforcing the safety and efficacy profile of Hemlibra in people with haemophilia A with factor VIII inhibitors seen in phase III HAVEN studies2,3,4
2019-12-09	Takeda	Results Takeda Demonstrates Its Long-Standing Commitment to Advancing Treatments for Rare Bleeding Disorders with Studies Highlighting Real-World Evidence and Investigational Gene Therapy at ASH 2019 takeda.com ↗ prophylaxis with rFVIII was estimated to be less costly and more effective over an estimated 70-year lifespan of a patient with severe hemophilia A.
2019-11-06	Hoffmann-La Roche	Results Roche to present new data highlighting breadth of haematology portfolio and pipeline at the American Society of Hematology 2019 Annual Meeting roche.com ↗ New analyses from the phase III HAVEN 3 study of Hemlibra® (emicizumab) in people with haemophilia A without factor VIII inhibitors will be presented.
2019-11-06	Genentech, Inc.	Results Genentech to Present New Data Highlighting Breadth of Hematology Portfolio and Pipeline at the American Society of Hematology 2019 Annual Meeting gene.com ↗ New analyses from the Phase III HAVEN 3 study of Hemlibra® (emicizumab-kxwh) in people with hemophilia A without factor VIII inhibitors will be presented.
2019-10-30	Chugai Pharmaceutical	Regulatory Chugai’s Hemlibra Approved for Hemophilia A without inhibitors in Taiwan chugai-pharm.co.jp ↗ Hemlibra was approved for hemophilia A without inhibitors in Taiwan on 22 October 2019
2019-10-18	Chugai Pharmaceutical	Results Data on the use of Chugai’s Hemlibra in Hemophilia A Children with or without Inhibitors were Published in Journals chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that two data on the use of Chugai’s hemophilia A treatment Hemlibra ® (emicizumab) in children were published in journals.
2019-07-09	Hoffmann-La Roche	Results Roche presents a broad range of data for Hemlibra demonstrating continued benefits for people with haemophilia A at the ISTH 2019 Congress roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data for Hemlibra® (emicizumab) across multiple pivotal studies in people with haemophilia A with and without factor VIII inhibitors at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress on 6-10 July in Melbourne, Australia.
2019-07-09	Chugai Pharmaceutical	Results Further Clinical Data including Long-Term Follow-up for Chugai’s Hemlibra Presented at ISTH chugai-pharm.co.jp ↗ Long-term follow-up from four phase III studies (HAVEN studies) shows Hemlibra’s sustained efficacy and safety in people with hemophilia A, with and without factor VIII inhibitors.
2019-07-08	Genentech, Inc.	Results Genentech Presents a Broad Range of Data for Hemlibra (Emicizumab-kxwh) Demonstrating Continued Benefits for People With Hemophilia A at the ISTH 2019 Congress gene.com ↗ Further data from the four pivotal HAVEN clinical trials were presented, demonstrating the long-term safety, efficacy and quality of life benefit of Hemlibra in people with hemophilia A with and without factor VIII inhibitors.
2019-03-14	Hoffmann-La Roche	Regulatory European Commission approves Roche's Hemlibra for people with severe haemophilia A without factor VIII inhibitors roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors.
2019-03-14	Chugai Pharmaceutical	Regulatory Chugai’s Hemlibra Receives Approval for Severe Hemophilia A without Factor VIII Inhibitors from the European Commission chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Roche received the decision from the European Commission confirming that Hemlibra ® (emicizumab), a hemophilia A treatment originated by Chugai, has EU marketing authorization for routine prophylaxis of bleeding episodes in adults and children with severe hemophilia A (congenital factor VIII deficiency, FVIII<1%) without factor VIII inhibitors.
2019-02-04	Chugai Pharmaceutical	Regulatory Chugai’s Hemlibra ® Gains Positive CHMP Opinion in Severe Hemophilia A without Inhibitors chugai-pharm.co.jp ↗ The CHMP has also adopted a positive opinion for additional dosing options of every two weeks or every four weeks in adults and children with hemophilia A with factor VIII inhibitors.
2019-02-01	Hoffmann-La Roche	Regulatory CHMP recommends EU approval of Roche's Hemlibra for people with severe haemophilia A without factor VIII inhibitors roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in adults and children with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors.
2018-12-21	Chugai Pharmaceutical	Regulatory Chugai’s HEMLIBRA ® Subcutaneous Injection Receives Approval for Hemophilia A without Inhibitors and Extension of Dosing Interval chugai-pharm.co.jp ↗ The MHLW has also approved additional dosing options of every two weeks or every four weeks in people with hemophilia A with factor VIII inhibitors.
2018-12-04	Chugai Pharmaceutical	Regulatory Chugai’s HEMLIBRA ® Approved in Taiwan for the Treatment of Hemophilia A with Factor VIII Inhibitors chugai-pharm.co.jp ↗ “We are pleased that HEMLIBRA has received regulatory approval for hemophilia A with factor VIII inhibitors now in Taiwan,”
2018-12-04	Chugai Pharmaceutical	Results Results Presented from Primary Analysis of the Phase III HAVEN 2 Study with Chugai’s HEMLIBRA ® for Children with Hemophilia A with Inhibitors at the American Society of Hematology 2018 chugai-pharm.co.jp ↗ These data, including longer follow-up (median of 11 additional months of data for once weekly dosing) and new data for less frequent dosing schedules (every two weeks or every four weeks), demonstrated clinically meaningful control of bleeding.
2018-12-03	Hoffmann-La Roche	Results Roche's Hemlibra provided sustained bleed control in the largest pivotal study to date of children with haemophilia A with factor VIII inhibitors roche.com ↗ In updated results from the HAVEN 2 study with a median of 11 additional months of data, 76.9% (95% CI: 64.8; 86.5) of children with haemophilia A with factor VIII inhibitors treated with Hemlibra once weekly (n=65) experienced zero treated bleeds.
2018-12-03	Genentech, Inc.	Results Genentech’s Hemlibra (emicizumab-kxwh) Provided Sustained Bleed Control in the Largest Pivotal Study to Date of Children With Hemophilia A With Factor VIII Inhibitors gene.com ↗ Nearly 77 percent of children receiving Hemlibra once weekly experienced zero treated bleeds
2018-10-05	Chugai Pharmaceutical	Regulatory Chugai’s HEMLIBRA ® Receives Regulatory Approval from U.S. FDA for Hemophilia A without Inhibitors chugai-pharm.co.jp ↗ The FDA has also approved additional dosing options of every two weeks or every four weeks in adults and children with hemophilia A with factor VIII inhibitors.
2018-10-04	Genentech, Inc.	Regulatory FDA Approves Genentech’s Hemlibra (Emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors gene.com ↗ FDA Approves Genentech’s Hemlibra (Emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors
2018-08-30	Hoffmann-La Roche	Results Positive phase III results for Roche's Hemlibra for haemophilia A without factor VIII inhibitors published in New England Journal of Medicine roche.com ↗ Hemlibra prophylaxis significantly reduced bleeds compared to no prophylaxis
2018-08-30	Chugai Pharmaceutical	Results Results of Global Phase III Study with Chugai's HEMLIBRA ® for Hemophilia A without Inhibitors Published in the New England Journal of Medicine chugai-pharm.co.jp ↗
2018-08-29	Genentech, Inc.	Results Positive Phase III Results for Genentech’s HEMLIBRA® (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors Published in New England Journal of Medicine gene.com ↗ HEMLIBRA prophylaxis significantly reduced bleeds compared to no prophylaxis
2018-06-05	Hoffmann-La Roche	Regulatory FDA grants Priority Review to Roche’s Hemlibra for people with haemophilia A without factor VIII inhibitors roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra® (emicizumab-kxwh) for adults and children with haemophilia A without factor VIII inhibitors.
2018-06-05	Chugai Pharmaceutical	Regulatory Chugai’s HEMLIBRA ® Receives Priority Review Status from U.S. FDA for Hemophilia A without Inhibitors chugai-pharm.co.jp ↗ The FDA is expected to make a decision on approval by 4 October, 2018.
2018-06-04	Genentech, Inc.	Regulatory FDA Grants Priority Review to Genentech’s HEMLIBRA (emicizumab-kxwh) for People With Hemophilia A Without Factor VIII Inhibitors gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for HEMLIBRA® (emicizumab-kxwh) for adults and children with hemophilia A without factor VIII inhibitors.
2018-05-21	Hoffmann-La Roche	Results Roche’s Hemlibra reduced treated bleeds by 96 percent compared to no prophylaxis in phase III HAVEN 3 study in haemophilia A without factor VIII inhibitors roche.com ↗
2018-05-21	Chugai Pharmaceutical	Results Chugai Presents Results of Two Pivotal Phase III Studies for its Bispecific Antibody HEMLIBRA ® at WFH 2018 chugai-pharm.co.jp ↗ The results from HAVEN 3 study demonstrate that HEMLIBRA, which was created with Chugai’s proprietary antibody engineering technologies, can reduce the bleeding risk in people with hemophilia A without inhibitors.
2018-05-20	Genentech, Inc.	Results Genentech’s HEMLIBRA (emicizumab-kxwh) Reduced Treated Bleeds by 96 Percent Compared to No Prophylaxis in Phase III Haven 3 Study in Hemophilia A Without Factor VIII Inhibitors gene.com ↗ Genentech’s HEMLIBRA (emicizumab-kxwh) Reduced Treated Bleeds by 96 Percent Compared to No Prophylaxis in Phase III Haven 3 Study in Hemophilia A Without Factor VIII Inhibitors
2018-04-26	Chugai Pharmaceutical	Regulatory Chugai Files Applications for HEMLIBRA ® for the Treatment of Hemophilia A without Factor VIII Inhibitors and for Extension of Dosing Interval chugai-pharm.co.jp ↗
2018-04-17	Hoffmann-La Roche	Regulatory FDA grants Breakthrough Therapy Designation for Roche’s Hemlibra in haemophilia A without inhibitors roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Hemlibra® (emicizumab-kxwh) for people with haemophilia A without factor VIII inhibitors.
2018-04-17	Chugai Pharmaceutical	Regulatory Chugai’s HEMLIBRA ® Receives Breakthrough Therapy Designation from U.S. FDA for Hemophilia A without Factor VIII Inhibitors chugai-pharm.co.jp ↗
2018-04-16	Genentech, Inc.	Regulatory FDA Grants Breakthrough Therapy Designation For Genentech’s HEMLIBRA (emicizumab-kxwh) in Hemophilia A Without Inhibitors gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to HEMLIBRA® (emicizumab-kxwh) for people with hemophilia A without factor VIII inhibitors.
2018-03-23	Chugai Pharmaceutical	Regulatory Anti-Coagulation Factor IXa/X Humanized Bispecific Monoclonal Antibody HEMLIBRA ® Subcutaneous Injection Approved in Japan chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that the Ministry of Health, Labour and Welfare has approved its coagulation factor VIII substitute / anti-coagulation factor IXa/X humanized bispecific monoclonal antibody, “HEMLIBRA ® Subcutaneous Injection 30mg, 60mg, 90mg, 105mg, 150mg” [generic name: emicizumab (genetical recombination)] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with congenital factor VIII deficiency (hemophilia A) with factor VIII inhibitors.
2018-02-28	Chugai Pharmaceutical	Regulatory Chugai’s HEMLIBRA ® Approved by European Commission in Hemophilia A with Inhibitors chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Roche has received regulatory approval from the European Commission for HEMLIBRA ® (emicizumab) for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors.
2018-02-27	Hoffmann-La Roche	Regulatory European Commission approves Roche's Hemlibra for people with haemophilia A with inhibitors roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors.
2018-01-29	Chugai Pharmaceutical	Regulatory Chugai's HEMLIBRA ® Gains Positive CHMP Opinion in Hemophilia A with Inhibitors chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Roche has received notification that the EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for HEMLIBRA ® (emicizumab) for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors.
2018-01-26	Hoffmann-La Roche	Regulatory CHMP recommends EU approval of Roche’s Hemlibra for people with haemophilia A with inhibitors roche.com ↗ The CHMP has recommended Hemlibra for use in all age groups.
2017-12-09	Hoffmann-La Roche	Results Roche’s Hemlibra continued to substantially reduce bleeds in people with haemophilia A with inhibitors roche.com ↗ In updated results from the HAVEN 2 study with six additional months of data and 40 more children (younger than 12 years of age), 94.7% (95% CI: 85.4; 98.9) of children with haemophilia A with inhibitors who received Hemlibra prophylaxis had zero treated bleeds (n=57).
2017-12-09	Genentech, Inc.	Results Genentech’s HEMLIBRA (emicizumab-kxwh) Continued to Substantially Reduce Bleeds in People with Hemophilia A with Inhibitors gene.com ↗ Nearly 95 percent of children who received HEMLIBRA experienced zero treated bleeds
2017-12-07	Hoffmann-La Roche	Results Roche’s Hemlibra every four weeks controlled bleeds in phase III study in haemophilia A roche.com ↗ At this interim analysis after a median of 17 weeks of treatment, Hemlibra prophylaxis showed a clinically meaningful control of bleeding.
2017-12-07	Chugai Pharmaceutical	Results Chugai’s Emicizumab Every Four Weeks Showed Positive Interim Results in Phase III Study chugai-pharm.co.jp ↗ At this interim analysis after a median of 17 weeks of treatment, emicizumab prophylaxis demonstrated a clinically meaningful control of bleeding over time.
2017-12-06	Genentech, Inc.	Results Genentech’s HEMLIBRA (emicizumab-kxwh) Every Four Weeks Controlled Bleeds in Phase III Study in Hemophilia A gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive interim results from the Phase III HAVEN 4 study evaluating HEMLIBRA® (emicizumab-kxwh) prophylaxis dosed once every four weeks in adults and adolescents (12 years of age or older) with hemophilia A with and without inhibitors to factor VIII.
2017-11-20	Hoffmann-La Roche	Results Roche’s Hemlibra significantly reduced bleeds in phase III study in haemophilia A roche.com ↗ The study met its primary endpoint, showing a statistically significant and clinically meaningful reduction in the number of treated bleeds over time in people receiving Hemlibra prophylaxis every week compared to those receiving no prophylaxis.
2017-11-20	Chugai Pharmaceutical	Results Chugai’s Bispecific Antibody Emicizumab Meets Primary Endpoint in Phase III Study chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that the primary endpoint has been met for the global phase III HAVEN 3 (NCT02847637) study evaluating emicizumab (ACE910) subcutaneous injection, once a week and once every two weeks, in patients with hemophilia A (12 years of age or older) without inhibitors to factor VIII.
2017-11-19	Genentech, Inc.	Results Genentech’s Hemlibra (Emicizumab-kxwh) Significantly Reduced Bleeds in Phase III Study in Hemophilia A gene.com ↗ The study met its primary endpoint, showing a statistically significant and clinically meaningful reduction in the number of treated bleeds over time in people receiving HEMLIBRA prophylaxis every week compared to those receiving no prophylaxis.
2017-11-17	Chugai Pharmaceutical	Regulatory Chugai’s HEMLIBRA ® Receives the World’s First Regulatory Approval from FDA for Hemophilia A with Inhibitors chugai-pharm.co.jp ↗ This represents the first regulatory approval for HEMLIBRA ® around the world.
2017-11-16	Hoffmann-La Roche	Regulatory FDA approves Roche’s Hemlibra (emicizumab-kxwh) for haemophilia A with inhibitors roche.com ↗
2017-11-16	Genentech, Inc.	Regulatory FDA Approves Genentech’s Hemlibra (Emicizumab-kxwh) for Hemophilia A with Inhibitors gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved HEMLIBRA® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors.
2017-08-24	Hoffmann-La Roche	Regulatory FDA grants Priority Review to Roche’s emicizumab for haemophilia A with inhibitors roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adolescents and children with haemophilia A with factor VIII inhibitors.
2017-08-24	Chugai Pharmaceutical	Regulatory Chugai’s Emicizumab Receives Priority Review Designation by FDA for Hemophilia A with Inhibitors chugai-pharm.co.jp ↗
2017-08-23	Genentech, Inc.	Regulatory FDA Grants Priority Review to Genentech's Emicizumab for Hemophilia A with Inhibitors gene.com ↗ the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adolescents and children with hemophilia A with factor VIII inhibitors.
2017-07-21	Chugai Pharmaceutical	Regulatory Chugai Files a New Drug Application for Its Bispecific Monoclonal Antibody “Emicizumab” for the Treatment of Congenital Factor VIII Deficiency (Hemophilia A) with Factor VIII Inhibitors chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it filed a new drug application for its anti-coagulation factor IXa/X humanized bispecific monoclonal antibody emicizumab
2017-07-10	Hoffmann-La Roche	Results Positive phase III results for Roche’s emicizumab in haemophilia A published in The New England Journal of Medicine roche.com ↗ All 12 secondary endpoints in HAVEN 1 were positive, including an intra-patient comparison that showed emicizumab reduced bleed rate by 79% compared to prior prophylactic bypassing agents
2017-07-10	Genentech, Inc.	Results Positive Phase III Results for Genentech’s Emicizumab in Hemophilia A Published in The New England Journal of Medicine gene.com ↗ The primary endpoint showed a clinically meaningful and statistically significant reduction in treated bleeds of 87 percent (risk rate [RR]=0.13, p<0.0001) with emicizumab prophylaxis compared with on-demand (no prophylaxis; episodic use only) bypassing agents (BPAs).
2017-06-26	Hoffmann-La Roche	Results Roche’s emicizumab showed positive results in phase III studies (HAVEN 1 and HAVEN 2) in haemophilia A with inhibitors roche.com ↗ The primary endpoint was treated bleeds, and results showed a statistically significant and clinically meaningful reduction in bleed rate of 87% (risk rate [RR]=0.13, p<0.0001) with emicizumab prophylaxis compared with on-demand treatment with BPAs.
2017-06-26	Chugai Pharmaceutical	Results Chugai’s Bispecific Antibody Emicizumab to Present Results of Two Pivotal Phase lll Studies at ISTH chugai-pharm.co.jp ↗ Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced results from two global phase lll studies for Chugai’s bispecific antibody emicizumab (ACE910): the primary analysis of HAVEN 1 study (NCT02622321) and the interim analysis of HAVEN 2 study (NCT02795767).
2017-06-25	Genentech, Inc.	Results Genentech’s Emicizumab Showed Positive Results in Phase III Studies (HAVEN 1 And HAVEN 2) in Hemophilia A With Inhibitors gene.com ↗ The primary endpoint was treated bleeds, and results showed a statistically significant and clinically meaningful reduction in bleed rate of 87 percent (RR [risk rate]=0.13, p<0.0001) with emicizumab prophylaxis compared to on-demand treatment with BPAs.
2017-04-17	Hoffmann-La Roche	Results Roche announces positive interim results for emicizumab in phase III study of children with haemophilia A roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today interim results from the phase III HAVEN 2 study evaluating emicizumab prophylaxis in children less than 12 years of age with haemophilia A and inhibitors to factor VIII.
2017-04-16	Genentech, Inc.	Results Genentech Announces Positive Interim Results for Emicizumab in Phase III Study of Children with Hemophilia A gene.com ↗ At this interim analysis after a median of 12 weeks of treatment, emicizumab prophylaxis showed a clinically meaningful reduction in the number of bleeds over time.
2017-02-01	Takeda	Results New data from Shire aim to help close the diagnosis and treatment gap for people with Hemophilia takeda.com ↗ Results found a multi-fold increase in thrombin generation, indicating a potential thrombotic risk, for patients who receive the investigational agent combined with FEIBA or rFVIIa.
2016-12-22	Hoffmann-La Roche	Results Roche’s emicizumab for haemophilia A meets primary endpoint in phase III study roche.com ↗ The study showed a statistically significant reduction in the number of bleeds over time in people treated with emicizumab prophylaxis compared to those receiving no prophylactic treatment.
2016-12-22	Chugai Pharmaceutical	Results Chugai’s Bispecific Antibody “Emicizumab” for Hemophilia A Meets Primary Endpoint in Phase lll Study chugai-pharm.co.jp ↗ A statistically significant reduction in the number of bleeds was confirmed in patients treated with emicizumab prophylaxis compared to those receiving no prophylactic treatment.
2016-12-21	Genentech, Inc.	Results Genentech’s Emicizumab for Hemophilia A Meets Primary Endpoint in Phase III Study gene.com ↗ The study showed a statistically significant reduction in the number of bleeds over time in people treated with emicizumab prophylaxis compared to those receiving no prophylactic treatment.
2016-12-02	Takeda	Results Shire reports on four decades of real-world safety experience with FEIBA® [Anti-Inhibitor Coagulant Complex] takeda.com ↗ The data found a multi-fold increase in thrombin generation, indicating a potential thrombotic risk for patients who receive the investigational agent combined with an approved bypass agent for breakthrough bleeds.
2016-08-26	Chugai Pharmaceutical	Regulatory Chugai receives Orphan Drug Designation for Emicizumab chugai-pharm.co.jp ↗
2016-07-28	Chugai Pharmaceutical	Results Chugai’s Emicizumab Showed Continued Benefits in Patients with Hemophilia A chugai-pharm.co.jp ↗ The latest data analysis continued to show a promising profile of once-weekly subcutaneous injection of emicizumab in terms of safety and prophylactic efficacy, regardless of the presence of factor VIII inhibitors.
2016-05-26	Chugai Pharmaceutical	Results Chugai’s Bispecific Antibody “ACE910/Emicizumab” Phase l Data in Patients with Hemophilia A Published in The New England Journal Of Medicine Online chugai-pharm.co.jp ↗ In this first-in-patient Phase I study, a once-weekly subcutaneous injection of emicizumab demonstrated a clinically acceptable safety profile and a potential benefit for preventing bleeding in hemophilia A patients, both with and without factor VIII (FVIII) inhibitors.
2015-09-03	Genentech, Inc.	Regulatory U.S. FDA Grants Breakthrough Therapy Designation for Genentech's Investigational Medicine ACE910 for People With Hemophilia A With Factor VIII Inhibitors gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to ACE910 (RG6013, RO5534262) for the prophylactic treatment of people who are 12 years or older with hemophilia A with factor VIII inhibitors.

All press releases naming this drug 126 releases

Date	Issuer	Release
Show all 126 releases opens the full record — a long page

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 36 sources stand behind the page.

Field	Value	Cited text
Known as	Emicizumab	ClinicalTrials.gov intervention name — accepted as the source's own label NCT07158606 ↗ 30 NCT04431726 ↗ NCT03361137 ↗ NCT02795767 ↗ NCT03921294 ↗ NCT05500807 ↗ NCT04188639 ↗ NCT06998524 ↗ NCT05279924 ↗ NCT04303559 ↗ NCT04303572 ↗ Show 20 more sources
Known as	ACE910	“Emicizumab (ACE910), a recombinant humanized bispecific monoclonal antibody, provides factor VIII (FVIII) cofactor bridging function to restore hemostasis in people with hemophilia A.” PMID 29296836 ↗ Sep 2017
Known as	Emicizumab kxwh	ChEMBL registry synonym — accepted as the source's own label CHEMBL3833393 ↗
Known as	Hemlibra	“Emicizumab (Hemlibra, Roche, Basel, Switzerland) is a novel, bispecific, monoclonal antibody which can substitute for the function of activated FVIII by bringing activated...” NCT04621916 ↗ 3 “randomized to preemptive weekly Eloctate (rFVIIIFc) vs. weekly Emicizumab (Hemlibra) to prevent inhibitor formation” NCT04303559 ↗ “"Emicizumab", "HEMLIBRA®"” NCT06155955 ↗ NCT04030052 ↗
Known as	HEMLIBRA- emicizumab injection, solution	“HEMLIBRA- emicizumab injection, solution” NCT04690322 ↗
Action	Restore	“Emicizumab (ACE910) bridges activated factor IX and factor X to restore the function of activated factor VIII” PMID 28691557 ↗ Jul 2017
Modality	Monoclonal antibody	“Emicizumab is the first bispecific monoclonal antibody prophylactic therapy for PwHA” PMID 35939785 ↗ Dec 2022
Route	Subcutaneous	“will be administered by subcutaneous injection” NCT02196207 ↗