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.”