MRI contrast developer Epix Pharmaceuticals of Lexington, MA, has reached an agreement with the U.S. Food and Drug Administration (FDA) on a proposal to reread images collected in trials of its blood-pool MR angiography agent, Vasovist, the company reported.
Epix has received a letter from the FDA that confirms that the protocol design and statistical analysis agreed on by the agency and Epix adequately address objectives necessary to resubmit a new drug application (NDA) for Vasovist.
The company has initiated the rereading of images obtained in prior phase III studies, and expects to submit those results in mid-2008. Vasovist has been approved for marketing in 33 countries outside of the U.S., Epix said.
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