Tuesday, June 30, 2009

FDA Approves AMAG's Iron Drug, Feraheme

AMAG Pharmaceuticals has just received Food and Drug Administration approval for Feraheme, an intravenous iron replacement therapy that treats iron deficiency anemia in adults with chronic kidney disease (CKD).

Feraheme is the first IV iron-based therapy to be approved in almost a decade, and it is expected to bring significant changes in the way adults with chronic kidney disease are treated.

"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."

A complete Feraheme treatment takes much less time than current therapies (such as Venofer or Ferrlecit). A complete treatment load can be delivered with just two injections (510 mg each) over a span of eight days.

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.


1 comments:

Kevin said...

Actually, the Feraheme PI says the second dose can be given "3-8 days" after the first. So, a full course of iron therapy may be delivered in as few as 4 days. Patients are going to love this.