EPIX Pharmaceuticals Reaches Agreement With FDA On Protocol, Initiates Re-Read Of Vasovist(TM) Phase 3 Images

EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on its proposal for the re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist™ (gadofosveset trisodium). EPIX has 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 (NDA) for Vasovist. EPIX has initiated the re-read of images obtained in prior Phase 3 studies. Vasovist has been approved for marketing in 33 countries outside of the U.S.

MedicalNewsToday