FDA greenlights Epix blood pool MRA agent

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The FDA has approved for marketing Epix Pharmaceuticals blood pool magnetic resonance angiography (MRA) agent, Vasovist (gadofosveset trisodium), to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

AIOD occurs when iliac arteries become narrowed or blocked and may prevent the sufficient transport of oxygen and/or blood throughout the body.

Vasovist is the first contrast agent approved for marketing in the United States for use with MRA, according to the Lexinton, Mass.-based company. Vasovist had previously been approved for marketing in 34 countries outside the United States based on data from four multi-center, phase 3 trials that showed that Vasovist’s accuracy was similar to that of catheter-based x-ray angiography, as determined by blinded readings.