Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B
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
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
