European Commission Approves Pfizer's Hympavzi for Hemophilia A and B

Key Insights

• The European Commission has approved Pfizer's Hympavzi for routine prevention of bleeding episodes in hemophilia A and B patients aged 12 and older.
• Hympavzi is the first once-weekly subcutaneous treatment in the EU for severe hemophilia B, offering a new administration route.
• The approval extends to patients with severe hemophilia A, providing the first pre-filled pen or syringe option in the EU.

Pfizer has received approval from the European Commission for its Hympavzi treatment, indicated for the routine prevention of bleeding episodes in patients 12 years and older with severe hemophilia A or B without inhibitors. This decision marks a significant advancement in hemophilia care within the European Union.

Hympavzi stands out as the first once-weekly subcutaneous treatment available in the EU for individuals with severe hemophilia B. Furthermore, it is the first treatment option, for both severe hemophilia A and B, that can be administered via a pre-filled pen or syringe, offering a more convenient and potentially less intimidating administration method for patients.

The approval by the European Commission follows the U.S. Food and Drug Administration's (FDA) approval of Hympavzi in October, highlighting the growing recognition of its clinical value. This approval allows for the broader use of Hympavzi, potentially improving the quality of life for numerous patients with hemophilia across Europe.