FDA official announcements and safety communications

Pfizer's HYMPAVZI, First Once-Weekly Treatment for Hemophilia A and B Without Inhibitors, Approved by FDA

Oct 11, 2024, 06:18 PM

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved HYMPAVZI™ (marstacimab-hncq), a once-weekly subcutaneous injection, marking the first once-weekly hemophilia B treatment. The drug is approved for adults and adolescents aged 12 years and older with Hemophilia A without factor VIII inhibitors or Hemophilia B without factor IX inhibitors. HYMPAVZI™ is designed for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with the two main types of hemophilia, a potentially deadly genetic disorder that impairs blood clotting. This approval represents Pfizer's second FDA approval for hemophilia in six months and is also the first FDA-approved hemophilia treatment that can be administered using a pre-filled auto-injector pen.