Schering/Epix’ Vasovist
This article was originally published in The Gray Sheet
Executive Summary
Formal appeal of vascular imaging agent Vasovist "approvable" letters is filed June 30 with FDA, seeking final agency clearance. The appeal "underscores our confidence in the clinical profile and benefits of Vasovist," developer Epix states. The most recent of two approvable letters issued to date for the magnetic resonance angiography agent, received last November, indicated that at least one additional trial, and a re-read of images obtained in certain of the previously completed Phase III trials, would be required prior to approval. The company also requests that an advisory committee be used as part of the appeal process. Vasovist (gadofosveset) marketing partner Schering AG was recently acquired by Bayer (1"The Gray Sheet" June 26, 2006, p. 13)...