Pediatric label update for hemophilia B drug Alprolix by FDA

The US Food and Drug Administration has approved updated labeling for Alprolix (coagulation Factor IX [recombinant], Fc Fusion Protein), an extended half-life therapy for the treatment of adults and children with hemophilia B, from Bioverativ (Nasdaq: BIVV), the hemophilia business spun out in February this year by US biotech major Biogen (Nasdaq: BIIB).

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 the product. These updates are based on interim data from the Phase III B-YOND open-label extension trial and final data from the Phase III Kids B-LONG pediatric study.

Notwithstanding the positive news, Bioverativ’s shares closed down 2.1% at $49.50 on Monday.