REGULATORY NEWS

FDA fast tracks AMAG alternative to gadolinium-based agents

Written by Editorial Staff   
August 27, 2008
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The FDA has granted fast track designation to AMAG Pharmaceuticals’ ferumoxytol for its development as a diagnostic agent for vascular-enhanced MRI (VE-MRI) to improve the assessment of peripheral arterial disease in patients with known or suspected chronic kidney disease.

If approved for an imaging indication, ferumoxytol could offer an alternative to gadolinium-based contrast agents, which are required to contain a black-box warning, according to the Cambridge, Mass.-based AMAG. In October 2007, the FDA asked manufacturers to include a new boxed warning for severe kidney insufficiency patients on the product labeling of all gadolinium-based contrast agents for MRI.

“We plan to initiate a phase II study of ferumoxytol for VE-MRI for the detection of clinically significant arterial stenosis or occlusion in subjects with intermittent claudication in the third quarter,” said Brian J.G. Pereira, MD, president and CEO of AMAG.
Last updated on September 22, 2008 at 5:14 am EST