EPIX resubmits MRA contrast agent application for Vasovist
EPIX Pharmaceuticals, a biopharmaceutical company, Monday resubmitted its new drug application (NDA) for its blood pool MR angiography (MRA) agent, Vasovist, to the FDA.
If approved, Vasovist (gadofosveset trisodium) will be the first contrast agent approved for marketing in the United States for use with MRA, a non-invasive modality for imaging blood vessels, according to the Lexington, Mass.-based company. In 2007, there were approximately 1.3 million MRA procedures performed in the United States using contrast agents.
In August 2006, the FDA denied EPIX’s application for Vasovist. In its response, the FDA also turned down the company’s request for an advisory committee to review the imaging agent.
“We look forward to continuing to work with the FDA to bring Vasovist to market in the United States,” said Michael G. Kauffman, MD, PhD, CEO of EPIX. “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."
If approved, Vasovist (gadofosveset trisodium) will be the first contrast agent approved for marketing in the United States for use with MRA, a non-invasive modality for imaging blood vessels, according to the Lexington, Mass.-based company. In 2007, there were approximately 1.3 million MRA procedures performed in the United States using contrast agents.
In August 2006, the FDA denied EPIX’s application for Vasovist. In its response, the FDA also turned down the company’s request for an advisory committee to review the imaging agent.
“We look forward to continuing to work with the FDA to bring Vasovist to market in the United States,” said Michael G. Kauffman, MD, PhD, CEO of EPIX. “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."