Biogen Idec Inc. reported Monday that the Food and Drug Administration has accepted its biologics license application for marketing approval for a fusion protein that would be used to treat hemophilia B.
The FDA granted the Weston company a standard review timeline, Biogen Idec added in a news 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, 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.”