EPIX reaches agreement with FDA over contrast agent

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Contrast enhanced thrombi image. Source: Epix Pharmaceuticals provided image to Nature.  

EPIX Pharmaceuticals reached agreement Thursday with the FDA on its proposal for the re-read of images that utilize its blood pool MR angiographic (MRA) contrast agent, Vasovist (gadofosveset trisodium). 

The Lexington, Mass.-based company said it has initiated the re-read of images obtained in prior Phase 3 studies.

EPIX said it received an action letter from the FDA confirming that the jointly agreed-upon protocol design and statistical analysis plan adequately address the objectives necessary to support the resubmission of the New Drug Application for Vasovist, which has been approved for marketing in 33 countries outside of the United States.