Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.

Read the Press Release announcing U.S. Marketing approval of Feraheme. Download the Feraheme Package Insert.

Feraheme is being developed to treat iron deficiency anemia associated with other conditions and disease states including women with abnormal uterine bleeding, and patients with cancer and gastrointestinal diseases.

Feraheme is also being developed as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease. For more information, please visit www.feraheme.com.

In 2009, we intend to advance our clinical Feraheme development programs for the treatment of iron deficiency anemia. A broad range of patients is being considered which may include women with abnormal uterine bleeding, patients undergoing various surgical procedures, and patients with cancer and gastrointestinal diseases. We are in discussions with the FDA to determine the potential design of these clinical development programs.

In addition to its use for the treatment of IDA, Feraheme may also be useful as a diagnostic agent for vascular enhanced magnetic resonance imaging (MRI) because of its potential to improve the visualization of blood vessels. This could result in magnetic resonance images with enhanced vascular contrast. There are currently no iron-based vascular contrast agents approved for MRI in the U.S. The currently approved contrast agents used for MRI in the U.S. are all gadolinium-based and are associated with rare but severe adverse events in patients with chronic kidney disease.

The initial focus of our clinical development of Feraheme as an imaging agent is in patients with peripheral arterial disease (PAD).

In 2008, we initiated a Phase II study of Feraheme in vascular-enhanced MRI for the detection of clinically significant arterial stenosis or occlusion in subjects with PAD. We expect this study to enroll approximately 100 patients. We have received Fast Track designation from the FDA for this indication.

Feraheme® is a registered trademark of AMAG Pharmaceuticals, Inc.