| Revision as of 09:53, 27 September 2024 editBioMed-03 (talk | contribs)30 edits hemophilia A← Previous edit | Revision as of 19:19, 11 October 2024 edit undoAllthemilescombined1 (talk | contribs)Extended confirmed users2,325 edits The FDA approved Hympavzi on October 11, 2024 for Hemophilia A and B patients ages 12 and older without inhibitors.Next edit → | ||
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| === Legal status === | === Legal status === | ||
| In September 2024, the ] of the ] adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Hympavzi, intended for prophylaxis of bleeding episodes in people aged twelve years of age and older, weighing at least {{convert|35|kg|lb}}, who have severe hemophilia A or B.<ref name="Hympavzi EPAR" /> The applicant for this medicinal product is Pfizer Europe Ma EEIG.<ref name="Hympavzi EPAR">{{cite web | title=Hympavzi EPAR | website=] (EMA) | date=19 September 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hympavzi | access-date=21 September 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> | In September 2024, the ] of the ] adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Hympavzi, intended for prophylaxis of bleeding episodes in people aged twelve years of age and older, weighing at least {{convert|35|kg|lb}}, who have severe hemophilia A or B.<ref name="Hympavzi EPAR" /> The applicant for this medicinal product is Pfizer Europe Ma EEIG.<ref name="Hympavzi EPAR">{{cite web | title=Hympavzi EPAR | website=] (EMA) | date=19 September 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hympavzi | access-date=21 September 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> | ||
| The ] approved Hympavzi on October 11, 2024 for Hemophilia A and B patients ages 12 and older without inhibitors.<ref name="FDA">{{cite news |title=FDA Approves New Treatment for Hemophilia A or B |url=https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hemophilia-or-b?utm_source=sfmc&utm_medium=email&utm_campaign=FDA+Alert+10.11.24&utm_term=https%3a%2f%2fwww.fda.gov%2fnews-events%2fpress-announcements%2ffda-approves-new-treatment-hemophilia-or-b&utm_id=376239&sfmc_id=19282767 |access-date=11 October 2024 |work=FDA.gov |date=October 11, 2024}}</ref> | |||
| === Names === | === Names === | ||
Revision as of 19:19, 11 October 2024
MedicationPharmaceutical compound
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| Other names | PF-06741086 |
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Marstacimab is an experimental monoclonal antibody intended for the treatment of hemophilia A and B. It is being developed by Pfizer.
Society and culture
Legal status
In September 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Hympavzi, intended for prophylaxis of bleeding episodes in people aged twelve years of age and older, weighing at least 35 kilograms (77 lb), who have severe hemophilia A or B. The applicant for this medicinal product is Pfizer Europe Ma EEIG.
The FDA approved Hympavzi on October 11, 2024 for Hemophilia A and B patients ages 12 and older without inhibitors.
Names
Marstacimab is the international nonproprietary name.
References
- ^ "Hympavzi EPAR". European Medicines Agency (EMA). 19 September 2024. Retrieved 21 September 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- "FDA and EMA Accept Marstacimab Regulatory Submissions for the Treatment of Hemophilia A and B". Pfizer (Press release). 9 December 2023. Retrieved 21 September 2024.
- "FDA Approves New Treatment for Hemophilia A or B". FDA.gov. 11 October 2024. Retrieved 11 October 2024.
- World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information. 33 (1). hdl:10665/330896.
External links
- Clinical trial number NCT03938792 for "Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B" at ClinicalTrials.gov
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