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Epix Pharmaceuticals Files Formal Appeal for Vasovist with the Center for Drug Evaluation and Research
LEXINGTON, Mass., February 28, 2007 -- EPIX Pharmaceuticals, Inc. today announced that it has submitted a formal appeal to Steven Galson, M.D., director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) asking the CDER director to approve the company's novel blood-pool imaging agent Vasovist (gadofosveset trisodium injection). In the filing, EPIX has asked that an Advisory Committee be considered as part of the appeal process. The company expects that the CDER director will respond to its submission within approximately 30 days, although any decision could be postponed until an Advisory Committee meeting if CDER grants the company's request for one.
"As we said at the end of last year, we had planned to file a formal appeal to the Center for Drug Evaluation and Research in the first quarter of 2007," said Andrew Uprichard, M.D., president of EPIX Pharmaceuticals. "Vasovist has been approved for clinical use in the European Community, Canada, Norway, Iceland, and Australia for the visualization of abdominal and peripheral vascular disease and in Switzerland for magnetic resonance angiography (MRA) of the whole body. We are hopeful that we will have the opportunity to present data from our four Phase 3 trials along with other data collected on Vasovist to an Advisory Committee as part of the appeal process."
Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through MRA. 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. Vasovist is marketed by Bayer Schering Pharma AG, Germany.
Posted: February 2007
- 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 to File Appeal with the Center for Drug Evaluation and Research for Vasovist - December 14, 2006
- 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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