प्राथमिक स्रोत रिकॉर्ड
निर्णायकEMA की राय
Pfizer: यूरोपीय आयोग (EC) ने इनहिबिटर वाले हीमोफीलिया A/B के लिए HYMPAVZI को मंजूरी दी
The European Commission granted marketing authorization for HYMPAVZI (marstacimab) in adults and adolescents ≥12 years (≥35 kg) with hemophilia A or B and inhibitors. The approval is based on Phase 3 BASIS data showing 93% reduction in treated ABR versus on-demand therapy and sustained low bleeding rates in the open-label extension.
मुख्य तथ्य
- फाइल किया गया
- 13 मई 2026, 10:45 am
- घटना
- EMA की राय
- दिशा
- सकारात्मक
- कंपनी
PFEफाइजर- संपत्ति
- marstacimab-hncq
- विश्वसनीयता
- स्रोत सहित
- p value
- <0.0001
- treated ABR OD
- 19.78 (95% CI: 16.12-24.27)
- extension ABR mean
- 1.19 (95% CI: 0.72-1.95)
- extension ABR median
- 0.00 (95% CI: 0.00-1.18)
- treated ABR HYMPAVZI
- 1.39 (95% CI: 0.85-2.29)
- treated ABR reduction
- 93%
स्रोत का अंश
European Commission Approves Pfizer's HYMPAVZI for the Treatment of Adults and Adolescents with Hemophilia A or B With Inhibitors European Commission Approves Pfizer's HYMPAVZI for the Treatment of Adults and Adolescents with Hemophilia A or B With Inhibitors European Commission Approves Pfizer’s HYMPAVZI for the Treatment of Adults and Adolescents with Hemophilia A or B With Inhibitors Approval in patients ages 12 and older based on Phase 3 data demonstrating superior bleed reduction to on-demand therapy, with continued benefit observed in open-label extension study HYMPAVZI is the only once-weekly subcutaneous treatment approved in the EU for both people living with hemophilia A or B, with or without inhibitors Pfizer Inc. (NYSE: PFE) today announced that the European Commission (E