BioCentury
ARTICLE | Clinical News

Biogen Idec, SOBI report Phase III data for hemophilia A

November 1, 2012 1:34 AM UTC

Biogen Idec Inc. (NASDAQ:BIIB) and partner Swedish Orphan Biovitrum AB (SSE:SOBI) reported top-line data showing that rFVIIIFc as prophylaxis met the primary efficacy and safety endpoints in the Phase III A-LONG trial to treat hemophilia A patients. To meet the efficacy endpoint, the partners said rFVIIIFc as prophylaxis needed to reduce annualized bleeding rates by 50% or more compared to on-demand treatment with rFVIIIFc. Biogen Idec did not disclose the reduction in bleeding rates, but did report that rFVIIIFc led to overall median annualized bleeding rates, including spontaneous and traumatic bleeds, of 3.6 in the weekly prophylaxis arm and 1.6 in the individualized prophylaxis arm vs. 33.6 in the on-demand episodic treatment arm. The open-label, international Phase III A-LONG trial enrolled 165 previously treated male hemophilia A patients aged 12 and older.

Biogen Idec plans to submit a BLA to FDA for rFVIIIFc in 1H13. The partners expect to submit an MAA to EMA by 2015 after completing the Phase III Kids A-LONG trial, which is evaluating rFVIIIFc in patients under age 12 with severe hemophilia A and a history of 50 or more exposure days with any marketed Factor VIII product. rFVIIIFc is long-acting recombinant fusion protein consisting of the Fc domain of human IgG1 attached to Factor VIII. ...