Biogen says FDA starts review of hemophilia B drug
WESTON, Mass. (AP) — Biogen Idec Inc. said Monday that the Food and Drug Administration is now reviewing its application for a new hemophilia treatment.
The company's drug rFIXFc is designed to treat hemophilia B, and Biogen said it lasts longer than current drugs. That would allow patients to endure fewer treatments. Biogen said the FDA will conduct a 10-month review, which means a decision would be due by early January.
Biogen said rFIXFc was effective in clinical trials when patients received a dose every one to two weeks. The company said current treatments can require more than 100 injections a year.
Hemophilia is a rare, inherited disorder that affects blood clotting. Hemophilia B affects only males, and patients have little or none of a blood clotting protein called factor IX.
Biogen and Sweden's Orphan Biovitrum are also studying a treatment for hemophilia A, which is more common and is caused by a different deficiency. Biogen plans to file for marketing approval of that treatment in the next few months.
Shares of Biogen Idec rose 39 cents to $169.09 in afternoon trading.