FDA Grants Fast Track Designation to Amag’s Ferumoxytol
The FDA has granted fast track designation to Amag Pharmaceuticals’s ferumoxytol for its development as a diagnostic agent for vascular-enhanced magnetic resonance imaging 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 highlighting the risks of using gadolinium-based agents in patients with advanced kidney disease.
Brian Pereira, president and CEO of Amag Pharmaceuticals, said: “We plan to initiate a Phase II study of ferumoxytol for vascular-enhanced magnetic resonance imaging for the detection of clinically significant arterial stenosis or occlusion in subjects with intermittent claudication in the third quarter of 2008. We look forward to continuing our collaborative relationship with the FDA in the ongoing development of ferumoxytol.”