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ARTICLE | Clinical News

Biogen Idec reports Kids A-LONG data for hemophilia A therapy

April 11, 2014 12:26 AM UTC

Biogen Idec Inc. (NASDAQ:BIIB) and partner Swedish Orphan Biovitrum AB (SSE:SOBI) said Eloctate (rFVIIIFc) as prophylaxis met the primary endpoint of the frequency of developing Factor Vlll inhibitors in the Phase III Kids A-LONG trial to treat and prevent bleeding in hemophilia A patients. No patients developed an inhibitor in the open-label trial. On secondary endpoints, Eloctate led to an overall median annualized bleeding rate (ABRs) of two and a median ABR for spontaneous bleeds of 0, with 46% of patients experiencing no bleeding episodes. Kids A-LONG enrolled 71 boys less than 12 years of age with severe hemophilia A and a history of 50 or more exposure days to commercially available Factor VIII therapies.

Biogen Idec conducted Kids A-LONG to support submission of an MAA to EMA, which requires the inclusion of pediatric study data in an MAA for a new hemophilia therapy. Swedish Orphan said it expects Biogen Idec to submit the MAA next half. A BLA for Eloctate is under FDA review to treat hemophilia A. The PDUFA date is not disclosed, but Biogen Idec said it is planning for a U.S. launch in mid-2014. Eloctate is a long-acting recombinant fusion protein consisting of the Fc domain of human IgG1 attached to Factor VIII. ...