Shots:
- The CHMP has recommended Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively
- The opinion was based on data of 116 subjects (12-75yrs.) from a pivotal P-III (BASIS) study treated with marstacimab (300mg loading dose followed by 150mg then 300mg, QW) for over 12mos. active treatment period vs RP or OD IV treatments for 6mos. observational period. Results from ongoing inhibitor cohort are anticipated in Q3’25
- The EC’s decision is anticipated in the upcoming mos. and will be valid across the EU plus Iceland, Liechtenstein & Norway. It is also under the US FDA’s review (PDUFA: Q4’24)
Ref: Pfizer | Image: Pfizer | Press Release
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