Schering AG/Epix Vasovist (MS-325)
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA is asking 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," the company says July 1. The firm announced that FDA accepted its May 23 "complete response" to a January "approvable" letter, setting a user fee goal date of Nov. 23. However, "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…approvable letter," Epix explained. CEO Michael Webb acknowledged that Epix is "not yet in agreement with the FDA," but has maintained that the complete response addresses the agency's concerns (1Pharmaceutical Approvals Monthly June 2005, p. 5)...