Biogen Idec Inc., a Weston biotechnology company, said Monday that the US Food and Drug Administration has accepted the company’s biologics license application for the marketing approval of a fusion protein for the treatment of hemophilia B.
The FDA granted the company a standard review timeline, Biogen Idec added in a press release.
Recombinant FIXFc is the first product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of reducing the burden of treatment for hemophilia B, the company said.
“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, M.D., senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec’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.”