AMAG Pharmaceuticals Inc. said Jan. 22 that the U.S. Food and Drug Administration has rejected its application for wider use of its iron deficiency drug Feraheme (ferumoxytol) because of safety concerns. The news brought shares of the company down 7% in mid-day trading.
The company is seeking approval to use Feraheme, an intravenous drug, in all adult, iron deficiency anemia patients who cannot tolerate an oral iron treatment. The drug was approved to treat iron deficiency anemia in chronic kidney disease patients in 2009.
In a complete response letter, the FDA said that AMAG has not provided sufficient information to permit labeling of Feraheme for safe and effective use for the proposed indication. The FDA suggested that AMAG generate additional clinical trial data in the proposed broad iron deficinecy patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death. The FDA also proposed potentially evaluating alternative dosing and/or administration of Feraheme. AMAG said it is assessing the content and recommendations of the letter and plans further discussions with the FDA.