AMAG reports Phase III data for Feraheme in iron deficiency anemia

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) reported data from a Phase III trial in 1,997 patients with iron deficiency anemia regardless of the cause who failed or could not tolerate oral iron therapy showing that 1.02 g IV Feraheme ferumoxytol reduced the rate of severe hypophosphatemia, a secondary endpoint defined as a serum phosphate level of <2 mg/dL, vs. 1.5 g IV Injectafer ferric carboxymaltose (0.4% vs. 39.7%). Data were presented at the American Society of Nephrology meeting in New Orleans.

In May, Feraheme met the primary endpoint in the double-blind, U.S. trial of non-inferiority to Injectafer in the proportion of patients with moderate to severe hypersensitivity reactions, including anaphylaxis, and moderate to severe hypotension based on a non-inferiority margin of 2.64% (0.6% vs. 0.7%, p≤0.0001 for non-inferiority). Feraheme also met all secondary endpoints including non-inferiority to Injectafer on a composite safety endpoint of moderate to severe hypersensitivity reactions; serious cardiovascular events and death; superiority to Injectafer on mean increase in hemoglobin per gram of iron administered; and non-inferiority to Injectafer on mean improvement in hemoglobin...