Shots:
- The EC has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs., at least 35kg) with hemophilia A & B, without FVIII & FIX inhibitors, respectively. It is valid across the EU plus Iceland, Liechtenstein & Norway
- Approval was based on pivotal P-III (BASIS) study of Hympavzi in patients (12-75yrs.) with severe hemophilia A or mod. severe to severe hemophilia B with/without inhibitors
- Study showed a reduction in the annualized bleeding rate (ABR) by 35% (5.08 vs 7.85) during 12mos. with Hympavzi vs routine prophylaxis & on-demand treatment. Safety aligned with the P-I/II study, with most common AEs being injection site reactions, headache, pruritus & hypertension
Ref: Pfizer | Image: Pfizer | Press Release
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