Amag’s Feraheme Label Application Reject by FDA

Amag Pharmaceuticals have received a setback for their anaemia drug, Feraheme, after the US Food and Drug Administration (FDA) rejected Amag’s application to expand the drug’s label.

The regulatory agency issued a complete response letter for the supplemental New Drug Application to increase 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 US regulatory body stated that Amag Pharmaceuticals has not submitted adequate information to authorise labelling of Feraheme for safe and effective use of the proposed indication.

The FDA proposed that Amag generate additional clinical trial data for Feraheme in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events and death.  The regulatory affairs agency also suggested evaluating alternative dosing and/or administration of the drug.

Steve Caffe, chief development and regulatory officer at Amag, commented that the company continues “to believe that approval of the Feraheme sNDA would provide physicians with an important treatment option for patients with IDA.”

Caffe added that in the coming weeks, “we intend to work with the FDA to determine the best regulatory path.”


Industry News