Epix Pharmaceutical Inc.’s intravascular contrast agent Vasovist was approved by US regulators to test for aortoiliac occlusive disease, (AIOD) or narrowing of the arteries that pass through the pelvis, in patients who have or may have peripheral vascular disease.

 

AIOD may prevent the sufficient transport of oxygen and/or blood throughout the body. Those affected with AIOD may not receive the blood and oxygen they need throughout their legs, causing pain, sores or gangrene, which can result in the loss of a limb.

 

Vasovost, or gadofosvesest trisodium, is the first contrast agent approved for use with magnetic resonance angiography (MRA). The procedure is a less invasive procedure than x-ray angiography, allowing for reduced patient discomfort and recuperation time and unlike x-ray angiography, MRA does not expose patients to ionizing radiation. In 2007, there were approximately 1.3 million MRA procedures performed in the United States using contrast agents not specifically approved for this procedure.

 

Vasovist has been approved in 34 other countries, including the European Union countries, based on clinical data showing imaging with Vasovist is about as accurate as imaging with catheter-based X-ray angiography.

 

“Vasovist is a first-in-class contrast agent with several unique characteristics that we believe will allow it to become a market leader in the United States,” said Elkan Gamzu, Ph.D., interim chief executive officer of Epix.

 

The approval in the United States was based on the results from a blinded, independent re-read of images of Vasovist from previous phase 3 studies. The re-read, which was conducted earlier this year, met all pre-specified endpoints prospectively agreed to with the Food and Drug Administration. The ruling marks the first U.S. regulatory approval for an Epix product.