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Oct 01, 2012
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Long Acting rFactor lX: Phase III data

Top-line data from the open-label, international Phase III B-LONG trial in 123 evaluable previously treated hemophilia B patients aged 12 and older showed that rFIXFc as prophylaxis met the primary efficacy and safety endpoints. To meet the efficacy endpoint, the partners said rFIXFc as prophylaxis needed to reduce annualized bleeding rates by >=50% compared to on-demand treatment with rFIXFc. Biogen Idec did not disclose the reduction in bleeding rates, but did report that rFIXFc led to overall median annualized bleeding rates, including spontaneous and traumatic bleeds, of 2.95 in the weekly prophylaxis arm and 1.38 in the individualized interval prophylaxis arm vs. 17.69 in the on-demand episodic treatment arm. rFIXFc was generally well tolerated with no...

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