Amag Pharmaceuticals has suffered a setback after the US Food and Drug Administration rejected its application to get the label expanded on its anaemia drug Feraheme.

The agency has issued a complete response letter for the supplemental New Drug Application to expand use of Feraheme (ferumoxytol) beyond the current chronic kidney disease indication to include all adult iron deficiency anaemia (IDA) patients who have failed or cannot tolerate oral iron treatment. In the letter, the FDA stated that AMAG has not provided sufficient information to permit labelling 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 IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events and death. The agency also proposed potentially evaluating alternative dosing and/or administration of Feraheme.

Steve Caffe, chief development and regulatory officer at Amag, said "we continue to believe that approval of the Feraheme sNDA would provide physicians with an important treatment option for patients with IDA". He added that in the coming weeks, "we intend to work with the FDA to determine the best regulatory path".