Biogen Idec Inc., a provider of therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders, has submitted a Biologics License Application, or BLA, to the FDA for the marketing approval of recombinant factor IX Fc fusion protein, or rFIXFc, for the treatment of hemophilia B.
rFIXFc is the product that is being developed with the goals of reducing the burden of treatment for this condition and enhancing protection from bleeding. The regulatory submission was based on results from B-LONG, the largest registrational Phase III clinical study in hemophilia B to date.
"The submission to FDA of rFIXFc is an important milestone towards the introduction of a long-lasting factor IX therapy which is the first major treatment advance for the hemophilia B community in 15 years," said Glenn Pierce, senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec's hemophilia therapeutic area.
"Our Fc fusion technology uses a natural pathway in the body to keep factor in circulation longer. The clinical efficacy and safety data for rFIXFc were robust and showed that dosing every one to two weeks provided significant protection from bleeding. Based on these data, we believe rFIXFc has the potential to have a major impact on the global adoption of prophylactic treatment in hemophilia B, helping patients prevent bleeding episodes and potentially reduce their long-term consequences."