U.S. Label Update for ALPROLIX® Adds Data Reinforcing Efficacy and Safety of Long-Term Prophylactic Treatment in Adults, Adolescents and Children with Hemophilia B
BIOVERATIV INC COMMON (BIVV)
Last bioverativ inc common earnings: 2/13 04:15 pm
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Source: Business Wire
WALTHAM, Mass.--(BUSINESS WIRE)-- Bioverativ Inc. (NASDAQ: BIVV), a global biopharmaceutical company dedicated to transforming the lives of people with rare blood disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the leading extended half-life therapy for the treatment of adults and children with hemophilia B. The label update, including the addition of pediatric data showing prophylactic treatment with ALPROLIX results in effective bleed protection with extended dosing intervals, further supports the long-term efficacy and safety profile of ALPROLIX. These updates are based on interim data from the Phase 3 B-YOND open-label extension trial and final data from the Phase 3 Kids B-LONG pediatric study. ALPROLIX is a recombinant clotting factor therapy developed using Fc fusio
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