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Epix Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist
LEXINGTON, Mass., December 14, 2006 -- EPIX Pharmaceuticals, Inc. today announced that it will submit a formal appeal to the director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) asking the director to overrule the decision by the Office of New Drugs (OND) denying a previously submitted appeal for its novel blood-pool imaging agent Vasovist (gadofosveset trisodium injection). The company anticipates submitting the appeal in the first quarter of 2007.
This appeal is in response to OND's denial in August 2006 of EPIX's appeal to OND of two approvable letters. The decision to appeal from OND to the CDER director was made because EPIX vigorously disagrees with CDER's previous determinations that Vasovist has not been shown to be safe and effective for identifying problematic stenosis in the peripheral vasculature. EPIX also plans to reiterate its request for FDA to convene an advisory committee before deciding on this new appeal. The company believes that where, as here, there is clear-cut scientific disagreement FDA should not refuse a request to allow external experts to provide their independent viewpoints. The time needed for the CDER director to hear the appeal will depend on whether FDA agrees to convene an advisory committee and, if so, how long that process takes.
Andrew Uprichard, M.D., president of EPIX Pharmaceuticals, said, "We are very pleased that regulatory authorities for the European Community, Switzerland, Canada, and Australia have already approved Vasovist for the visualization of peripheral vascular disease. We look forward to approval in the U.S."
Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography. The initial target indication for Vasovist is for use in magnetic resonance angiography imaging of non-coronary vascular disease. Vasovist has been approved for marketing in 30 countries including all 25 member states of the European Union, Norway, Iceland, Switzerland, Australia and Canada, where it is marketed by Schering AG, Germany.
Posted: December 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 Receives Response from the FDA Regarding Appeal of Vasovist Approvable Letters - August 28, 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
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