April 25, 2008 - EPIX Pharmaceuticals Inc. met all pre-specified endpoints prospectively agreed to with the FDA in a blinded, independent re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist (gadofosveset trisodium), and plans to resubmit a New Drug Application (NDA) to the FDA for Vasovist in mid-2008.
There are currently no contrast agents approved in the United States for use with MRA, a noninvasive modality for imaging blood vessels. However, it is estimated that approximately 1.5 million MRAs will be conducted in the U.S. during 2008 using gadolinium-based products.
"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 U.S. regulatory approval," said Andrew Uprichard, M.D., president and head of research and development at EPIX. "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 United States."
The company said it believes these positive results position it well for FDA approval and, if approved, will serve a large and unmet need in the U.S. MRA market. The company hopes to work with the FDA to achieve approval for Vasovist by the end of 2008. Currently, there are no MRA imaging agents approved in the United States, however, unapproved gadolinium-based agents are used for MRA. Vasovist is currently approved for marketing in 33 countries.
For more information: www.epixpharma.com