Today, Biogen Idec announced that its Biologics License Application (BLA) has been accepted by the US Food and Drug Administration (FDA) for the marketing approval of its hemophilia A treatment.
Eloctate (recombinant factor VIII F c fusion protein) is the first hemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed to provide long-lasting production and reduce the burden of treatment for hemophilia A patients. The drug candidate uses a naturally occurring pathway to delay destruction of factor and cycles it back into the bloodstream for a longer circulating half-life.
“Eloctate has the potential to improve adherence by reducing the number of intravenous injections needed to prevent bleeds, which is an important need for people with hemophilia A,” Glenn Pierce, MD, PhD, Senior Vice President of Global Medical Affairs and Chief Medical Officer at Biogen Idec’s hemophilia therapeutic area stated. “For those people currently on preventative – or prophylactic – treatment, Eloctate provides the potential to reduce the number of intravenous injections by 50 to 100 per year.”
Current hemophilia A treatments can require approximately 150 to 180 injections per year for prophylaxis factor VIII products.
The acceptance of the Eloctate’s BLA was based on results from a Phase III clinical study known as A-LONG. This is the largest registrational Phase III clinical study in hemophilia A. Results found that patients who injected the drug once-weekly to twice-weekly had low annualized bleeding rates. Hemophilia A patients typically require prophylaxis injections three times per week or every other day to keep a sufficient circulating level of factor VIII.
Factor VIII is needed to prevent bleeding episodes for patients with this rare, inherited disorder that impairs a person’s blood to clot. Hemophilia A occurs in roughly one in 5,000 male births per year. If untreated, bleeding events could lead to pain, irreversible joint damage, and life-threatening hemorrhages.
In addition to Eloctate, Biogen’s hemophilia B candidate’s BLA was recently accepted by the FDA. Alprolix’s (recombinant factor IX Fc fusion protein) BLA was accepted by the FDA on March 4. Both products are being developed and commercialized in partnership by Biogen Idec and Swedish Orphan Biovitrum (Sobi). Biogen leads development, has manufacturing rights and commercial rights in North America and all other regions excluding the Sobi territory.
Source: Biogen Idec
Last Updated: 5/13/13; 2:40PM EST