FDA Accepts EPIX Pharmaceuticals' (EPIX) Submission Following Vasovist(TM) Approvable Letter As Complete Response; FDA Action Targeted For Late November 2005
10/19/2005 5:09:24 PM
CAMBRIDGE, Mass.--(BUSINESS WIRE)--July 1, 2005--EPIX Pharmaceuticals, Inc. (Nasdaq: EPIX) today announced that the FDA has accepted EPIX' submission of May 2005 as a complete response to the approvable letter received from the U.S. Food and Drug Administration (FDA) in January 2005 for Vasovist(TM) (MS-325). The FDA indicated that it would review EPIX' NDA, including the May 2005 submission with a target date for an action letter in late November 2005. The FDA also encouraged EPIX to consider a re-read of the images from the Phase III trials to provide additional information about the usefulness of dynamic versus steady state images, and to schedule a meeting with the FDA to discuss the merits and design of such a study. EPIX agreed to schedule such a meeting as promptly as possible. EPIX asked that the FDA conduct its review of the NDA, including the complete response, in parallel with those discussions, and the FDA agreed to do so. If approved, Vasovist will establish a new class of blood pool contrast agents for magnetic resonance angiography (MRA) to diagnose vascular disease.
In its response submitted to the FDA in May 2005, EPIX provided new analyses of existing data, including new analyses of the manner in which the non-contrast comparator scans were performed in the Phase III trials. The company believes these new analyses provide additional support for the conclusion that Vasovist is effective. EPIX' response did not include efficacy data from new clinical trials, which were requested by the FDA to demonstrate efficacy prior to approval in the January 2005 approvable letter.