Biogen says FDA starts hemophilia drug review

Biogen says FDA is reviewing 2 of its hemophilia drugs after accepting Eloctate application

Associated Press

WESTON, Mass. (AP) -- Biogen Idec Inc. said Monday that the Food and Drug Administration is reviewing its experimental drug Eloctate as a treatment for hemophilia A. Its shares rose almost 4 percent by midday.

Biogen asked the FDA to review the drug in March, and the FDA has accepted that application. Eloctate is intended to be injected once or twice a week, making it a longer-lasting treatment for the condition. Other treatments are taken three or four times a week.

Hemophilia is a rare, inherited disease that affects blood clotting. Hemophilia A occurs in approximately one out of every 5,000 male births. Those with the disease don't have enough of a blood clotting protein called factor VIII.

In March the FDA started a review of Biogen's drug Alprolix as a treatment for hemophilia B, which is less common and is caused by a different deficiency. Both reviews are expected to take 10 months.

Shares of Biogen Idec rose $8.07, or 3.8 percent, to $221.29 in midday trading. They are trading near the high end of their 52-week range of $126.39 to $226.18.

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