AMAG wins Fast Track designation from FDA

AMAG Pharmaceuticals Inc., a Cambridge biopharmaceuticals company, said today that the US Food and Drug Administration has granted Fast Track designation to a diagnostic agent that can be used during vascular-enhanced magnetic resonance imaging procedures.

The agent, called ferumoxytol, improves the assessment of peripheral arterial disease in patients with known or suspected chronic kidney disease, or CKD, the company said.

In a press release, AMAG added that if approved, ferumoxytol, as an iron-based imaging agent, "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."

"We are very pleased that the FDA has recognized ferumoxytol's potential to address an important unmet medical need for a safe agent that facilitates the diagnosis of arterial abnormalities in patients with compromised kidney function," Brian J.G. Pereira, AMAG's president and chief executive, said in a statement. "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 (leg pain with walking) in the third quarter of 2008."

In its press release, AMAG noted that Fast Track is a designation that the FDA reserves for products intended to treat a serious or life threatening condition and that demonstrate the potential to address unmet medical needs for that condition.
(By Chris Reidy, Globe staff)