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May 13, 2013
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Feraheme ferumoxytol: Additional Phase III data

A subgroup analysis of 344 patients with abnormal uterine bleeding in the double-blind, international Phase III IDA-301 trial showed that 1 g IV Feraheme significantly increased the proportion of patients who achieved a >=2 g/dL increase in hemoglobin at any time from baseline to week 5, the co-primary endpoint for a U.S. regulatory submission, vs. placebo (87.3% vs. 3.6%, p<0.0001). Feraheme also significantly increased mean hemoglobin from baseline to week 5, the co-primary endpoint for an EU regulatory submission, vs. placebo (2.8 vs. 0 g/dL, p<0.0001). Additionally, Feraheme led to a...

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