Epix resubmits drug application
EPIX Pharmaceuticals Inc. of Lexington announced today that it has resubmitted a new drug application to the Food and Drug Administration for Vasovist, an imaging agent for diagnosing vascular disease.
The biopharmaceutical company, which expressed the hope that Vasovist will gain US approval by the end of the year, noted in its press release that Vasovist has been approved for marketing in 33 countries, including member states of the European Union, Switzerland, Turkey, Australia, and Canada.
Nearly two years ago, the FDA denied approval for Vasovist, and Epix said at the time that the FDA had suggested that additional testing was needed.
In a statement included in today's press release, Epix chief executive Michael G. Kauffman said: "Throughout the appeal process for Vasovist, we worked closely with the FDA, and the resubmission is a culmination of the work done by our team at Epix. We remain hopeful that we will achieve approval for Vasovist by the end of 2008 and are focused on executing our strategy to monetize our interest in this valuable asset."
Epix describes Vasovist as an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through magnetic resonance angiography imaging, or MRA.
To read additional coverage about Vasovist, please click here.
(By Chris Reidy, Globe staff)
