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ARTICLE | Company News

Complete response for Feraheme in broader population

January 23, 2014 2:05 AM UTC

FDA issued a complete response letter for an sNDA from AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) seeking to expand the label of anemia drug Feraheme ferumoxytol to include treatment of all adults with iron deficiency anemia who have failed or could not tolerate oral iron treatment. The IV iron replacement therapy is already approved to treat iron deficiency anemia in adults with chronic kidney disease (CKD).

According to AMAG, FDA said the company "has not provided sufficient information to permit labeling of Feraheme for safe and effective use" for the broader anemia indication. The company said FDA said more information, including additional clinical trial data, was needed. According to AMAG, the agency suggested a trial in the broad iron deficiency anemia population with a primary composite safety endpoint of serious hypersensitivity and anaphylaxis, cardiovascular events and death. FDA also proposed evaluating alternative dosing and/or administration of Feraheme. ...