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news.Epix Pharmaceuticals has announced that the FDA has approved for marketing its novel blood pool magnetic resonance angiography, or MRA, agent, Vasovist to evaluate aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease.
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Vasovist is the first contrast agent approved for marketing in the US for use with MRA, a non-invasive modality for imaging blood vessels, the company said.
Vasovist had previously been approved for marketing in 34 countries outside the US based on data from four multi-center, Phase III 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 Epix Pharmaceuticals.
Elkan Gamzu, interim CEO of Epix Pharmaceuticals, said: “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 US. It offers good resolution angiography, a high signal per dose, a long imaging window timeframe and single-dose imaging of multiple vessel beds. We believe the resulting high-quality image will allow physicians to fully utilize MRA as a meaningful diagnostic and therapeutic tool.”