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Ferumoxytol Treatment Produced Significant Hemoglobin Increases In Adult Iron Deficiency Anemia Patients With Gastrointestinal Disease Who Had Failed Or Could Not Tolerate Oral Iron Therapy

Stocks in this article: AMAG

LEXINGTON, Mass., May 21, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) announced that a new sub-group analysis from IDA-301, a phase III, randomized, placebo-controlled clinical trial, will be presented today at a poster session of the Digestive Disease Week 2013 (DDW) meeting in Orlando, Florida. In the full IDA-301 study, 608 adult patients with iron deficiency anemia (IDA) who had failed or could not tolerate oral iron were treated with ferumoxytol and 200 received placebo. The sub-group analysis being presented today at DDW is based on 231 patients in IDA-301 with gastrointestinal (GI) disease. Of these patients, 173 were randomized to the ferumoxytol treatment arm and 58 to the placebo arm.

IDA-301 was a multicenter trial designed to compare the safety and efficacy of a one gram course of ferumoxytol versus placebo in adult patients with IDA who had failed or could not tolerate oral iron treatment, regardless of the underlying cause. Ferumoxytol is an IV iron treatment currently approved in the United States for the treatment of IDA in adult chronic kidney disease patients. IDA-301 was one of two studies that formed the foundation for AMAG's supplemental new drug application (sNDA) in the United States, which was filed in December 2012. AMAG's sNDA seeks to expand the use of Feraheme® (ferumoxytol) for adult IDA patients who have failed or could not tolerate oral iron, including those patients with GI disease.

The primary efficacy endpoint of this study for the U.S. Food and Drug Administration (FDA) is the proportion of subjects who achieved a > 2.0 g/dL increase in hemoglobin at any time from baseline to week 5; the primary efficacy endpoint for European Union (EU) regulators is the mean change in hemoglobin from baseline to week 5. In the GI sub-group analysis, 82.1% of ferumoxytol-treated patients achieved an increase of > 2.0 g/dL in hemoglobin compared to 1.7% of patients who received placebo at week 5, meeting the protocol defined measure of superiority (p<0.0001). The mean change in hemoglobin in ferumoxytol-treated GI patients from baseline to week 5 was 2.8 g/dL, compared to no increase (-0.1 g/dL) in GI patients receiving placebo (p<0.0001). These results paralleled those in the total study population.

As a pre-defined secondary endpoint in the IDA-301 study, patients were asked to report on measures of fatigue using the Functional Assessment of Chronic Illness Therapy (FACIT) instrument. Patients in the GI sub-group treated with ferumoxytol demonstrated an 11.6 point improvement in self-reported fatigue compared to a 7.9 point improvement in those who received placebo (p=0.0335).

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