AMAG MRI agent gets on FDA fast track
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.
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.