The FDA has approved Feraheme (ferumoxytol injection, from AMAG Pharmaceuticals) for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD). This approval was based on data from four Phase 3 clinical studies of patients with CKD and iron deficiency anemia. These studies consisted of three open-label, multicenter, randomized, safety and efficacy studies and a fourth double-blind, multicenter, randomized, placebo-controlled, cross-over safety study. Each of the three safety and efficacy studies achieved statistical significance in its primary endpoint, the mean change in hemoglobin from baseline at Day 35 after the first dose. Feraheme significantly increased hemoglobin levels compared to oral iron across the spectrum of CKD. Overall, 1,726 patients were exposed to Feraheme in the development program, including 1,562 patients with all stages of CKD.
Feraheme is expected to be available during the second half of July 2009.
For more information call (617) 498-3300 or visit www.amagpharma.com.