LEXINGTON, Mass.—The U.S. Food and Drug Administration has approved AMAG Pharmaceuticals' Feraheme Injection for intravenous use as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease, according to a June 30 news release.
"Iron deficiency anemia is a significant problem in patients with chronic kidney disease and is frequently underdiagnosed and undertreated," said Bryan Becker, MD, president of the National Kidney Foundation. "We welcome the availability of a new therapy option for chronic kidney disease patients affected by iron deficiency anemia."
Feraheme is expected to be commercially available in the United States during the second half of July 2009, according to AMAG. Feraheme will be distributed primarily through wholesalers and specialty distributors.
In addition, AMAG said it will market and sell Feraheme through its commercial organization consisting of approximately 150 professionals, including an 80-person specialized sales force, an experienced account management and reimbursement team, and a contract nurse team.
The recommended dose of Feraheme is an initial 510 mg IV injection followed by a second 510 mg IV injection three to eight days later, according to AMAG. Feraheme should be administered as an undiluted IV injection delivered at a rate of up to 1 mL/sec (30 mg/sec). The recommended Feraheme dose may be re-administered to patients with persistent or recurrent iron deficiency anemia.
"Feraheme offers patients across the continuum of chronic kidney disease, including patients not on dialysis and patients on dialysis, a new paradigm for the treatment of iron deficiency anemia," said Brian J.G. Pereira, MD, president and CEO of AMAG. "We are extremely pleased with the FDA's approval of Feraheme, and we are well prepared and excited to bring this new treatment option to patients and physicians."
