Reuters: Regulatory News: UPDATE 1-Amag's anemia drug meets late-stage study goal

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UPDATE 1-Amag's anemia drug meets late-stage study goal Jul 18th 2012, 11:01 Wed Jul 18, 2012 7:01am EDT July 18 (Reuters) - Amag Pharmaceuticals Inc said its anemia drug met the main goal of improving hemoglobin levels of patients in a late-stage study that tested the drug in patients with iron deficiency anemia. The drug Feraheme, which is already approved for the treatment of iron deficiency anemia in adult chronic kidney disease patients, is now being tested as a treatment for iron deficiency anemia regardless of the underlying cause. Amag said the results showed statistically significant increase in hemoglobin level in patients on Feraheme compared with patients in the placebo group. The study was testing the efficacy of Feraheme on targets set by U.S. and EU health regulators and the trial met both the goals. "With both phase III studies in our global registrational program for Feraheme now complete, we will seek approval for Feraheme for the treatment of a broader population of patients with iron deficiency anemia," Lee Allen, Amag's chief medical officer, said in a statement. The company plans to submit a supplemental new drug application for Feraheme by the end of this year. Shares of the Lexington, Massachusetts-based company closed at $15.85 on Tuesday on the Nasdaq.

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