Biogen Idec recently announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologic License Application (BLA) for its hemophilia B drug.
The FDA granted a standard review timelines for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B. Recombinant FIXFc is the first product candidate in a new class of long-lasting clotting factor therapies that are being developed to reduce the burden of treatment for the disease. The candidate is being developed using the company’s novel and proprietary monomeric Fc fusion technology. This platform provides a longer circulating half-life that is a result of the technology, which makes use of a naturally occurring pathway that delays the destruction of factor and cycles it back into the bloodstream.
“We are encouraged by the FDA’s acceptance of our application, as we believe rFIXFc has the potential to transform the care of hemophilia B by allowing for less frequent injections and helping patients to maintain low annualized bleeding rates,” Glenn Pierce, MD, PhD, senior vice president of Global Medical Affairs and chief medical officer of Biogen’s hemophilia therapeutic area said in a statement. “We are working with the FDA to bring the first major treatment advance for the hemophilia B community in 15 years.”
Submission of the BLA was based on results from the largest registrational phase III clinical study in hemophilia to date known as B-LONG. The study shows that rFIXFc provides long-lasting protection from bleeding with fewer injections than required in the current standard of care.
Biogen Idec’s BLA Submission for rFVIIIFc is on track for filing during the first half of 2013. Recombinant FVIIIFc is intended for patients with hemophilia A.
Source: Biogen Idec
Last Updated: 3/5/13; 10:55AM EST