Epix Pharmaceuticals Inc., has announced that it has received a letter from the US Food and Drug Administration (FDA) denying Epix's formal appeal to approve its novel blood-pool imaging agent Vasovist (gadofosveset trisodium) and turning down Epix's request for an Advisory Committee to review Vasovist.
In its response letter, the office of new drugs (OND) of the FDA 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 to the OND on June 30, 2006 in response to two prior approvable letters for Vasovist.
"We are disappointed by the Agency's action. We are evaluating several options available to us as next steps with Vasovist in the US, 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.
Dr Uprichard added, "We remain committed to bringing Vasovist to market in the US. Vasovist was approved throughout the European Union late last year and is already being marketed in several countries within Europe. Vasovist was also recently recommended for approval in Australia."
Vasovist is an injectable intra vascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography. EPIX's initial target indication for Vasovist is for use in magnetic resonance angiography imaging of non-coronary vascular disease.