Shots:
- US FDA granted approval to Pfizer’s Beqvez, based on BENEGENE-2 (P-III) study (n=45) to treat of Haemophilia B adult patient using factor IX (FIX) prophylaxis therapy, with life-threatening hemorrhage, spontaneous bleeding episodes, no FDA-approved test detected neutralizing antibodies to AAVRh74var capsid; met 1EP of non-inferiority in the ABR of total bleeds
- Based on durability response of patients to Beqvez, Pfizer launching a warranty program to provide greater certainty to payers, maximize access for eligible patients, and financial protection against risk of efficacy failure
- BEQVEZ, a one-time treatment enables haemophilia B patients to produce FIX themselves rather than FIX SOC (IV; multiple times wk or mos); awaits assessment by EMA; gained regulatory clearance in Canada
Ref: Pfizer | Image: Pfizer | Press Release
Related News:- X4 Pharmaceuticals’ Xolremdi Receives the US FDA’s Approval for the Treatment of WHIM Syndrome
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