Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.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.
Subscribe to our email newsletter
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.”