EPIX denied by FDA in imaging agent clearance appeal
EPIX Pharmaceuticals Inc. said Tuesday that the U.S. FDA has denied its appeal to approve its novel blood-pool imaging agent Vasovist (gadofosveset trisodium). In its response the FDA also turned down EPIX's request for an advisory committee to review Vasovist.
If the imaging agent is to ever be cleared for use, the FDA indicated that the company must conduct additional clinical research to support approval rather than relying on a blinded re-read of previously submitted data and data from a new clinical trial. Two all new clinical trials to support the application for approval would be more effective, the agency indicated.
"We are disappointed by the agency's action. We are evaluating several options available to us as next steps with Vasovist in the United States, including the option to appeal this decision to the next level at the FDA, and will update the market accordingly," said Andrew Uprichard, MD, president of EPIX Pharmaceuticals.
Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography. EPIX was granted marketing approved in October 2005 by the European Medicines Agency for all 25 member states of the European Union. Vasovist has also been approved in Switzerland thus far.