FDA Clears New MRA Agent
December 23, 2008 – The FDA approved for marketing EPIX Pharmaceuticals’ novel 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 reportedly the first contrast agent approved for marketing in the U.S. for use with MRA, a noninvasive modality for imaging blood vessels. Vasovist had previously been approved for marketing in 34 countries outside the U.S. based on data from four multicenter, Phase 3 clinical trials that showed that Vasovist’s overall accuracy was similar to that of catheter-based x-ray angiography, as determined by blinded readings.
According to the manufacturer, the approval was based on the positive results from a blinded, independent reread of images of Vasovist from previous Phase 3 studies. The re-read, which was conducted earlier this year, met all prespecified endpoints prospectively agreed to with the FDA.
It is reported that in the re-read Vasovist was demonstrated to have: statistically greater sensitivity, enabling readers of images using Vasovist more accurately detected disease when disease was present, compared with non-contrast MRA; statistically greater specificity so that readers of images using Vasovist more accurately excluded disease if it wasn’t present at a rate that was not worse than noncontrast MRA; and for scans deemed uninterpretable, Vasovist was demonstrated to have sensitivity and specificity that was significantly better than chance alone.
For more information: www.epixpharma.com