AMAG MRI agent gets on FDA fast track

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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.

“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.