EPIX files appeal with FDA in response to Vasovist approvable letter

By Lisa Kerner

Charlotte, N.C., June 30 - EPIX Pharmaceuticals, Inc., said it submitted a formal appeal to the Food and Drug Administration for its novel blood-pool imaging agent Vasovist. In addition, the company requested an Advisory Committee be used in the appeal process.

A response from the FDA is expected in approximately 30 days.

"The submission of this appeal is the next step in a long process and represents a substantial undertaking for our company and underscores our confidence in the clinical profile and benefits of Vasovist," president and chief operating officer Andrew Uprichard said in a company news release.

Vasovist is an injectable intravascular contrast agent used to provide visual imaging of the vascular system through magnetic resonance angiography.

EPIX said in November 2005 that the FDA had asked the company to conduct additional studies before granting approval to Vasovist - studies that the company said will require a substantial period of time to complete.

EPIX is a pharmaceutical company based in Cambridge, Mass. The company recently announced a definitive agreement to merge with Lexington, Mass.-based Predix Pharmaceuticals Holdings, Inc.

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