EMA — authorised 18 November 2024
- Application: EMEA/H/C/006240
- Marketing authorisation holder: Pfizer Europe MA EEIG
- Local brand name: Hympavzi
- Indication: Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with: severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII inhibitors, or severe haemophilia B (congenital factor IX deficiency, FIX < 1%) without factor IX inhibitors.
- Status: approved
The European Medicines Agency (EMA) has approved Hympavzi, a treatment for patients with severe haemophilia A or B. Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients aged 12 years and older, weighing at least 35 kg, with severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) or severe haemophilia B (congenital factor IX deficiency, FIX < 1%) without inhibitors. This approval aims to provide a new treatment option for patients with these conditions.