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Epix Pharmaceuticals Receives Response from the FDA Regarding Appeal of Vasovist Approvable Letters
LEXINGTON, Mass., August 28, 2006 - EPIX Pharmaceuticals, Inc. today announced that it has received a letter from the U.S. 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 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, M.D., president of EPIX Pharmaceuticals.
Dr. Uprichard added, "We remain committed to bringing Vasovist to market in the United States. 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 intravascular 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. In October 2005, the European Medicines Agency granted marketing approval of Vasovist for all 25 member states of the European Union. Vasovist has also been approved in Switzerland and recommended for approval in Australia.
Vasovist has been studied in 18 clinical trials totaling more than 1,400 patients. The clinical trials were conducted to determine comparability of Vasovist MRA to conventional catheter-based X-ray angiography for the identification and characterization of vascular stenosis. The studies included evaluation of a single bolus injection of Vasovist for diagnosis of non-coronary vascular disease in the aortoiliac, renal and pedal arteries.
Posted: August 2006
- EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium) - December 22, 2008
- EPIX Pharmaceuticals Announces Resubmission of New Drug Application for Vasovist - July 1, 2008
- EPIX Provides Update Regarding Status of Vasovist Appeal - April 2, 2007
- Epix Pharmaceuticals Files Formal Appeal for Vasovist with the Center for Drug Evaluation and Research - February 28, 2007
- Epix Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist - December 14, 2006
- FDA Extends Review of EPIX Pharmaceuticals’ Appeal of Vasovist Approvable Letters - July 28, 2006
- EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist Approvable Letters - June 30, 2006
- FDA Issues Approvable Letter for Blood-Pool Contrast Agent Vasovist - November 23, 2005
- EPIX Submits Response to FDA Approvable Letter - May 23, 2005
- FDA has completed its review of the NDA for MS-325 - January 14, 2005