FDA accepts submission to expand approval of Feraheme (ferumoxytol) to all adults with iron deficiency anemia.-AMAG Pharmaceuticals.

AMAG Pharmaceuticals announced that the FDA has accepted its submission to broaden the existing label for Feraheme (ferumoxytol) to include the treatment of all adults with iron deficiency anemia (IDA) who have an intolerance or unsatisfactory response to oral iron. The FDA has indicated a six-month review timeline and established a Prescription Drug User Fee Act (PDUFA) target action date of February 2, 2018. The current indication of Feraheme is limited to the treatment of IDA in adults with chronic kidney disease (CKD).

The submission is, in part, supported by positive results from a previously announced Phase III randomized, double-blind, non-inferiority clinical trial that evaluated Feraheme compared to Injectafer (ferric carboxymaltose injection) in approximately 2,000 adults with IDA who had failed or could not tolerate oral iron or in whom oral iron was contraindicated. The study met its pre-specified primary endpoint of demonstrating non-inferiority to Injectafer based on the primary composite endpoint of the incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) or moderate-to-severe hypotension.