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Nov 05, 2012
 |  BC Week In Review  |  Clinical News  |  Clinical Results

RFVIIIFc: Phase III data

Top-line data from the open-label, international Phase III A-LONG trial in 165 previously treated male hemophilia A patients aged 12 and older showed that rFVIIIFc as prophylaxis met the primary efficacy and safety endpoints. To meet the efficacy endpoint, the partners said rFVIIIFc as prophylaxis needed to reduce annualized bleeding rates by >=50% 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. rFVIIIFc was generally well...

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