Bioverativ receives FDA approval for ALPROLIX label update
Bioverativ (BIVV) announced that the U.S. Food and Drug Administration has approved updated labeling for ALPROLIX, the 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 fusion technology to prolong circulation in the body and has been studied in more than 150 adult, adolescent, and pediatric patients over 17,000 exposure days as part of its clinical development program.
The new label demonstrates additional clinical trial experience with 93 subjects treated prophylactically for more than 104 weeks.
The ALPROLIX label update is based on FDA review of results from B-YOND, an open-label, non-randomized extension study of previously-treated adults and adolescents enrolled in the Phase 3 B-LONG study and participants of Kids B-LONG, a Phase 3 study of children with severe hemophilia B.
In these trials, weekly prophylactic treatment with ALPROLIX resulted in a median spontaneous annualized bleeding rate of zero among children and 1.04 among adults and adolescents, and a median joint annualized bleeding rate of zero among children and 1.11 among adults and adolescents. Median overall ABRs for children, and adults and adolescents with weekly prophylactic treatment, were 1.97 and 2.95, respectively.
Updated pharmacokinetic data from these studies are also included in the label.
Obstructive uropathy was also added to the label as a common adverse reaction. Obstructive uropathy was reported in two subjects and the condition was resolved in both cases with hydration.
Other common adverse reactions include headache and oral paresthesia.
BIVV closed at $50.57.
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