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.