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FDA Approves First Long-acting rFIX Therapy

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FDA Approves First Long-acting rFIX Therapy

April 1, 2014

In March, Biogen Idec announced that the US Food and Drug Administration (FDA) approved ALPROLIX™, the company’s long-acting, recombinant factor IX (rFIX) Fc fusion protein therapy. The product, the first long-acting rFIX therapy, is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia B. The therapy has shown to reduce bleeding episodes with weekly prophylactic infusions. It is the first significant improvement in hemophilia B therapies in 17 years.

Approval of ALPROLIX™ was based on Phase 3 results from the B-LONG clinical studies in adolescents and adults with hemophilia B. Subjects demonstrated a prolonged circulation of rFIX in the body, lengthening the intervals between prophylactic infusions. The median overall dosing interval for those in the prophylaxis arm was 12.5 days. Further, more than 90% of bleeds were controlled by one infusion of the rFIX therapy. No participants developed an inhibitor to the product.

“The FDA approval of ALPROLIX is a significant milestone for the hemophilia B community, and represents an important first step in our commitment to transform the care of people with hemophilia,” said George A. Scangos, PhD, chief executive officer of Biogen Idec. “ALPROLIX offers people with hemophilia B the ability to prevent or reduce bleeding episodes with prophylactic infusions starting at least a week apart. We believe this new therapy will help more people with hemophilia and their caregivers realize the benefits of this treatment approach.”

“Hemophilia has a significant impact on people whom it affects, throughout their lives,” said Patrick F. Fogarty, MD, assistant professor of medicine at the Hospital of the University of Pennsylvania, and director, Penn Comprehensive Hemophilia and Thrombosis Program. “ALPROLIX™ addresses a critical need by allowing people with hemophilia B to maintain factor levels with prophylactic infusions once weekly or once every 10 days. We hope this will facilitate use of prophylactic therapy.” 

Health Canada also announced the approval of ALPROLIX™ on March 21, 2014. Biogen expects its new product to be commercially available in May.

Sources: Biogen press release dated March 28, 2014; Business Wire press release dated March 28, 2014