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news.Epix Pharmaceuticals has reported positive results from the blinded, independent re-read of images of its novel blood pool magnetic resonance angiographic agent, Vasovist.
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In the re-read of images obtained from previous phase III studies, Epix met all pre-specified endpoints prospectively agreed to with the FDA. Epix plans to resubmit a new drug application (NDA) to the FDA for Vasovist in mid-2008.
Andrew Uprichard, president and head of R&D at Epix, said: “We believe these positive results confirm the efficacy upon which the NDA was based and allow us to move forward with our strategy of achieving US regulatory approval. We worked closely with the FDA to design the protocol and statistical analysis plan for the re-read of these images and look forward to continuing our work with the FDA to bring Vasovist to market in the US.”