AMAG Pharmaceuticals, of Cambridge, Mass., today announced that the U.S. Food and Drug Administration has granted fast-track designation to its ferumoxytol product as a diagnostic agent for vascular-enhanced MRI.
The product is designed to assess peripheral arterial disease in patients with known or suspected chronic kidney disease.
If it is approved, it could offer an alternative to gadolinium-based contrast agents, which have a black box warning highlighting their risks for patients with advanced kidney disease, according to AMAG.
With the fast-track designation, the FDA can review a new drug application in a reduced amount of time, from 10 to six months. This facilitates the development process of products that aim to treat serious or life threatening conditions and exhibit the potential to address unmet medical needs for those conditions.
The company said it hopes to begin a Phase II study of the agent in the third quarter of the year.