Drugs / Lanadelumab
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed angioedema, hereditary, 4 5 milestones | |||||
| Filed | US (FDA) | TAKHZYRO | angioedema, hereditary, 4 | 2022-10-27 | “The U.S. FDA accepted Takeda’s supplemental biologics license application for TAKHZYRO to prevent hereditary angioedema (HAE) attacks in children from age 2 to <12.” takeda.com ↗ |
| Filed | Japan (PMDA) | TAKHZYRO | angioedema, hereditary, 4 | 2021-03-12 | “submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection” takeda.com ↗ |
| Filed | EU (EMA) | — | angioedema, hereditary, 4 | 2018-03-29 | “announced today the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for lanadelumab (SHP643)” takeda.com ↗ “European Medicines Agency (EMA) validated the marketing authorization application for lanadelumab in March 2018” takeda.com ↗ |
| Filed | Other | — | angioedema, hereditary, 4 | 2018-03-29 | “announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has validated the marketing authorization application (MAA) for lanadelumab (SHP643).” takeda.com ↗ “Health Canada accepted the New Drug Submission (NDS) for lanadelumab under Priority Review in March 2018” takeda.com ↗ “Health Canada has accepted Shire’s New Drug Submission (NDS) for lanadelumab under Priority Review” takeda.com ↗ |
| Filed | US (FDA) | — | angioedema, hereditary, 4 | 2018-02-23 | “U.S. Food and Drug Administration (FDA) accepted Shire's biologics license application (BLA) and granted priority review for lanadelumab in February 2018.” takeda.com ↗ “FDA accepted the Biologics License Application (BLA) and granted priority review for lanadelumab” takeda.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Takhzyro | — | 2018-11-22 | europa.eu ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT04848272 | Aug 2021 → Dec 2024 | lung disorder | St Vincent's Institute of Medical Research | Unknown | No outcome recorded |
| Phase 1 | NCT04460105 | Oct 2020 → Jan 2021 | pneumonia | Shire | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04503603 | Aug → Dec 2020 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03918239 | May → Nov 2019 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT03401671 | Jan → May 2018 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT02093923 | May 2014 → May 2015 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 1 | NCT01923207 | Aug 2013 → Jan 2014 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04422509 | Oct 2020 → Feb 2021 | COVID-19 | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05297786 | Jul 2022 → Sep 2024 | acute hypotension, dialysis disequilibrium syndrome | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT04278885 | Oct 2020 → Dec 2024 | F12-associated cold autoinflammatory syndrome | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 39 trials · 1 met primary · 2 missed | ||||||
| Phase 3 | NCT05460325 | Jun 2022 → Nov 2023 | hereditary angioedema | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT04687137 | Feb 2021 → Jun 2022 | hereditary angioedema | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT04444895 | Feb 2021 → May 2023 | angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT04590586 | Nov 2020 → Aug 2021 | COVID-19 | Amgen | Completed | Missed primary |
| Phase 3 | NCT04206605 | May 2020 → Oct 2022 | non-histaminic angioedema | Takeda | Completed | Missed primary |
| Phase 3 | NCT04180163 | Dec 2019 → Aug 2021 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT04070326 | Aug 2019 → Oct 2021 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02741596 | May 2016 → Oct 2019 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02586805 | Mar 2016 → Apr 2017 | hereditary angioedema | Shire | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06818474 | Jun 2024 → Sep 2027 expected | acquired angioedema | Bernstein Clinical Research Center | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04583007 | — | hereditary angioedema | Shire | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 30
| Date | Issuer | Release |
|---|---|---|
| 2025-02-24 | Takeda | Regulatory The European Medicines Agency (EMA) Has Approved an Additional Subcutaneous Administration Option for TAKHZYRO® (lanadelumab) for Patients Aged 12 Years and Above with Recurrent Attacks of Hereditary Angioedema (HAE) takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) announced today that the EMA has approved an additional 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab) for subcutaneous administration in adolescents (aged 12 years and above) and adult patients with hereditary angioedema. |
| 2023-02-04 | Takeda | Regulatory U.S. FDA Approves Takeda’s TAKHZYRO ® (lanadelumab-flyo) to Prevent Hereditary Angioedema (HAE) Attacks in Children 2 Years of Age and Older takeda.com ↗ |
| 2022-06-30 | Takeda | Results Takeda’s TAKHZYRO ® (lanadelumab) Demonstrated Positive Results in the Prevention of HAE Attacks in First and Only Open-Label Phase 3 Trial in Children Ages 2 to <12 Years takeda.com ↗ |
| 2022-04-12 | Takeda | Results TAKHZYRO ® (lanadelumab) Open Label Phase 3 Study Met its Objectives in Children Ages 2 to <12 Years of Age with Hereditary Angioedema (HAE) takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the Phase 3 SHP643-301 study ( NCT04070326 ) evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO ® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives. |
| 2022-03-28 | Takeda | Regulatory Takeda’s TAKHZYRO ® (lanadelumab) Approved in Japan for Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE) takeda.com ↗
Takeda (TSE:4502/NYSE:TAK) today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) for TAKHZYRO ® (lanadelumab) subcutaneous injection 300mg syringes for prophylaxis against acute attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older in Japan. |
| 2022-02-28 | Takeda | Results Interim Phase 4 Data Support TAKHZYRO ® (lanadelumab) as an Effective Treatment to Reduce Attacks in Hereditary Angioedema Patients takeda.com ↗
Data from both studies show that lanadelumab had marked reduction in attack rates, and that angioedema control was sustained for 12 months. |
| 2021-08-05 | Takeda | Results Final Results from the Longest Hereditary Angioedema Study of Active Treatment Duration Conducted to Date Support the Sustained Safety and Efficacy of TAKHZYRO® (lanadelumab) Injection for Long-Term Prevention of Hereditary Angioedema Attacks takeda.com ↗
The Phase 3 HELP Study™ Open-label Extension (OLE) showed preventative treatment with TAKHZYRO markedly reduced the frequency of hereditary angioedema (HAE) attacks by 87.4 percent overall compared to baseline over the course of approximately 2.5 years |
| 2021-07-09 | Takeda | Results New Data from the Phase 3 HELP Study ™ Open-Label Extension Evaluating Safety and Efficacy of TAKHZYRO ® (lanadelumab) for Hereditary Angioedema Patients to be Presented at European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress takeda.com ↗
An additional analysis further suggests TAKHZYRO was a well-tolerated treatment that prevented HAE attacks over an extended planned 132 week treatment period across specific HAE patient demographic and disease characteristic subgroups. |
| 2021-03-12 | Takeda | Regulatory Takeda Submits New Drug Application in Japan for Lanadelumab as a Preventive Treatment for Hereditary Angioedema Attacks takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE). |
| 2020-12-08 | Takeda | Regulatory Takeda Announces Approval of TAKHZYRO ® (lanadelumab) subcutaneous injection in China for the Treatment of Hereditary Angioedema takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that China’s National Medical Products Administration (NMPA) has approved TAKHZYRO ® (lanadelumab) subcutaneous injection for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older. |
| 2020-11-13 | Takeda | Results Final Results from the Phase 3 HELP Study ™ Open-Label Extension Support TAKHZYRO ® (lanadelumab-flyo) Injection as a Long-term Preventive Treatment Option in Patients with Hereditary Angioedema takeda.com ↗
Results were consistent with the safety and efficacy of TAKHZYRO in the pivotal trial. |
| 2020-06-06 | Takeda | Results New Data from the Phase 3 HELP Study Open-Label Extension Evaluate the Long-Term Safety and Efficacy of TAKHZYRO ® (lanadelumab) in Reducing Hereditary Angioedema Attacks takeda.com ↗
The analyses suggest that TAKHZYRO ® (lanadelumab) is well-tolerated and can prevent hereditary angioedema (HAE) attacks over an extended treatment period, with sustained and consistent reduction in monthly attack rate across a range of different patient subgroups. |
| 2020-05-29 | Takeda | Regulatory Takeda Receives Positive CHMP Opinion for Pre-filled Syringe Presentation of TAKHZYRO ® (lanadelumab) for use as a Preventive Treatment for Hereditary Angioedema Attacks takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on a Type II Variation regulatory application and recommended the approval of a pre-filled syringe presentation of TAKHZYRO ® (lanadelumab). |
| 2019-11-08 | Takeda | Results New Analyses from the Phase 3 HELP Study ™ Open-Label Extension in Hereditary Angioedema Evaluate Efficacy and Safety of TAKHZYRO ® (lanadelumab-flyo) Injection During Extended Study Treatment Period takeda.com ↗
The analyses, being presented at the 2019 American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting in Houston, Texas from November 7-11, showed that TAKHZYRO continued to prevent HAE attacks at a rate similar to that observed in the pivotal HELP Study, in patients who received treatment for a mean duration of 19.7 (0-26.1) months. |
| 2019-06-03 | Takeda | Results New Ad-hoc Analysis of Phase 3 HELP Study™ Evaluates Prevention of HAE Attacks with TAKHZYRO® (lanadelumab) During Early Treatment Phase takeda.com ↗
The analysis suggests that TAKHZYRO starts to prevent hereditary angioedema (HAE) attacks during this early treatment phase, with patients experiencing an 80.1% decrease in mean monthly attack rate compared to placebo. |
| 2018-11-30 | Takeda | Regulatory Shire Receives European Approval for TAKHZYRO™ (lanadelumab) subcutaneous injection, for the Preventive Treatment of Hereditary Angioedema takeda.com ↗
Dublin, Ireland – 30 November 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that the European Commission (EC) has granted Marketing Authorisation for TAKHZYRO™ (lanadelumab) subcutaneous injection, for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. |
| 2018-11-27 | Takeda | Results Shire plc: JAMA Publishes Complete Results of Phase 3 HELP Study™ Evaluating Lanadelumab as a Preventive Treatment for Hereditary Angioedema takeda.com ↗
Patients receiving lanadelumab 300 mg every two weeks had an 87% relative reduction in mean monthly attacks vs. placebo (0.26 vs. 1.97, n=27 vs. n=41) |
| 2018-11-16 | Takeda | Results Shire Announces New HELP Study(TM) Data for Lanadelumab in Hereditary Angioedema (HAE) at 2018 ACAAI Annual Scientific Meeting takeda.com ↗
These results were noted during the entire 26-week treatment period and, according to a post hoc sensitivity analysis, were greatest for patients during the 16-week steady state period (days 70-182). |
| 2018-10-19 | Takeda | Regulatory CHMP Recommends EU Marketing Authorisation of lanadelumab for the Prevention of HAE Attacks takeda.com ↗
This positive opinion marks an important step towards providing adults and adolescents living with HAE in Europe a first-of-its-kind monoclonal antibody treatment option to help prevent attacks, |
| 2018-09-20 | Takeda | Regulatory Santé Canada autorise TAKHZYRO(MC) (lanadelumab en injection), le premier traitement à anticorps monoclonal en son genre destiné à la prévention de crises d’angioœdème héréditaire (AOH) takeda.com ↗
Santé Canada a autorisé TAKHZYRO (lanadelumab en injection) pour la prévention courante des crises d’angioœdème héréditaire (AOH) chez les adultes et adolescents âgés de 12 ans et plus. |
| 2018-09-20 | Takeda | Regulatory Health Canada has authorized TAKHZYRO(TM) (lanadelumab injection), a first-of-its-kind monoclonal antibody treatment for the prevention of hereditary angioedema (HAE) attacks takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) and Shire Pharma Canada ULC (Shire Canada), the leading global biotechnology company focused on rare diseases, announced today that following priority review, Health Canada has authorized TAKHZYRO (lanadelumab injection) for routine prevention of attacks of hereditary angioedema (HAE) in adolescents and adults (12 years of age and older). |
| 2018-08-23 | Takeda | Regulatory Shire Announces FDA Approval of TAKHZYRO™ (lanadelumab-flyo), a First-of-its-Kind mAb Preventive Treatment for Hereditary Angioedema takeda.com ↗
Dublin, Ireland – August 23, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that following priority review, the U.S. Food and Drug Administration (FDA) has approved TAKHZYRO™ (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. |
| 2018-04-18 | Takeda | Regulatory The Swiss Agency for Therapeutic Products (Swissmedic) Validates Shire’s Marketing Authorization Application (MAA) for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab takeda.com ↗
The validation of the MAA confirms that the lanadelumab MAA submission is complete and that the formal review process will begin. |
| 2018-03-29 | Takeda | Regulatory Shire Reports Regulatory Milestones for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab takeda.com ↗
The European Medicines Agency (EMA) validates Shire’s Marketing Authorization Application for investigational Hereditary Angioedema (HAE) treatment lanadelumab. |
| 2018-03-03 | Takeda | Results New Data from Pivotal Phase 3 Study Investigating Lanadelumab as a Prophylactic Treatment for Hereditary Angioedema to be Presented at 2018 AAAAI/WAO Joint Congress takeda.com ↗
Findings show significant reduction of attacks and improvement in Angioedema Quality-of-Life scores in HAE patients receiving lanadelumab across all dosing regimens studied versus placebo |
| 2018-02-27 | Takeda | Regulatory The European Medicines Agency (EMA) Grants Accelerated Assessment for Shire’s Lanadelumab Being Evaluated for the Prevention of Attacks in Hereditary Angioedema (HAE) Patients Aged 12 Years and Older takeda.com ↗
Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted an accelerated assessment for lanadelumab (SHP643). |
| 2018-02-23 | Takeda | Regulatory FDA Accepts Shire’s Biologics License Application (BLA) and Grants Priority Review for Lanadelumab for the Prevention of Attacks in Hereditary Angioedema (HAE) Patients takeda.com ↗
Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG) today announced the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) and granted priority review for lanadelumab (SHP643). |
| 2018-02-13 | Takeda | Regulatory Shire Provides Regulatory Progress Update for Key Pipeline Programs Targeting Rare Disease takeda.com ↗
Health Canada has accepted Shire’s request for priority review for the New Drug Submission (NDS) for lanadelumab (SHP643), an investigational therapy for prevention of angioedema attacks in patients 12 years and older with hereditary angioedema (HAE). |
| 2017-05-18 | Takeda | Results Shire’s Investigational Treatment Lanadelumab Reduces Hereditary Angioedema Monthly Attack Rate by 87% Versus Placebo in Phase 3 26-week Pivotal Trial takeda.com ↗
The 300 mg dose administered once every two weeks resulted in a statistically significant reduction in mean HAE attack frequency of 87% compared to placebo (p <0.001). |
| 2017-02-23 | Takeda | Results New England Journal of Medicine Publishes Phase 1b Results for Shire’s Investigational Treatment for Hereditary Angioedema, a Rare Genetic Disease takeda.com ↗
In this Phase 1b study, no serious adverse events or discontinuations due to adverse events were observed at all doses studied. |
All press releases naming this drug 31 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lanadelumab | “Lanadelumab is a subcutaneously-administered monoclonal antibody inhibitor of plasma kallikrein in clinical development for prophylaxis of hereditary angioedema attacks.” PMID 29043014 ↗ Oct 201716“Lanadelumab (DX-2930) is a new kallikrein inhibitor with the potential for prophylactic treatment of hereditary angioedema with C1 inhibitor deficiency.” PMID 28225674 ↗ Feb 2017 |
| Known as | DX-2930 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02093923 ↗ |
| Known as | Lanadelumab (shp643) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545189 ↗ |
| Known as | Lanadelumab flyo | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545189 ↗ |
| Known as | SHP643 | “Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE” NCT02741596 ↗ |
| Known as | TAK-743 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04687137 ↗ |
| Known as | Takhzyro | “Lanadelumab Injection [Takhzyro]” NCT05297786 ↗ |
| Action | Inhibit | “DX-2930 is a human monoclonal antibody inhibitor of plasma kallikrein” PMID 24980392 ↗ Jun 20141“Plasma kallikrein inhibitor” CHEMBL3545189 ↗ |
| Modality | Monoclonal antibody | “DX-2930 is a human monoclonal antibody inhibitor of plasma kallikrein” PMID 24980392 ↗ Jun 2014 |
| Route | Subcutaneous | “single subcutaneous administration of DX-2930 or placebo” PMID 24980392 ↗ Jun 2014 |
| Target | KLKB1 | “Plasma kallikrein inhibitor” CHEMBL3545189 ↗ |