A Medical Device Daily

EPIX Pharmaceuticals (Lexington, Massachusetts) reported that it has reached an agreement with the FDA on its proposal for the re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist (gadofosveset trisodium).

Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through MRA. The initial target indication for Vasovist is for use in MRA imaging of the non-coronary vascular system.

Vasovist has been approved for marketing in 33 countries. The marketing rights to Vasovist are held by Bayer Schering Pharma in Europe and by Bayer HealthCare Pharmaceuticals in the U.S. and Canada. Both companies are part of Bayer AG.

EPIX is focused on developing therapeutics through the use of its in silico drug discovery platform.