EPIX imaging agent Vasovist denied; FDA urges two new clinical trials

By Elaine Rigoli

Tampa, Fla., Aug. 28 - EPIX Pharmaceuticals, Inc. has received a letter from the Food and Drug Administration denying the company's formal appeal to approve its novel blood-pool imaging agent Vasovist (gadofosveset trisodium) and turning down its request for an advisory committee to review Vasovist.

In its response letter, the FDA's Office of New Drugs also suggested that if EPIX decides to conduct additional clinical research to support approval, then rather than relying on a blinded re-read of previously submitted data and data from a new clinical trial, a safer course of action would be to conduct two new clinical trials to support the application for approval.

EPIX submitted the appeal June 30 in response to two prior approvable letters for Vasovist, an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography.

EPIX is a biopharmaceutical company based in Lexington, Mass.

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