Biogen Idec Hemophilia B Treatment Application Faces FDA Review

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Thursday, March 7, 2013

Biogen Idec said the U.S. Food and Drug Administration has accepted the company’s biologics license application for marketing approval of a fusion protein therapy designed to treat hemophilia B.

The FDA also granted the Weston-based company a standard review timeline.

The therapy, recombinant factor IX Fc fusion protein, 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, officials said.

The company added the regulatory submission was based on results from B-LONG, the largest registrational phase 3 clinical study in hemophilia B to date.

Contact
Ira Kantor
617-619-6496

Source: Boston Herald

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