Epix Pegs Vasovist Approval In Second Half 2007 Following Second “Approvable” Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s action letter for the vascular imaging agent requires an additional clinical trial and a re-read of images from previous trials.
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Epix anticipates approval for its vascular imaging agent Vasovist in 18 to 24 months, following receipt of the product's second "approvable" letter on Nov. 22. "The most recent approvable letter indicates that at least one additional clinical trial, and a re-read of images obtained in certain of the previously completed Phase III trials, will be necessary," the company said Nov. 23. Epix' partner Schering AG holds worldwide marketing rights for Vasovist (formerly MS-325). FDA's response was not a complete surprise considering that resubmission following a January 2005 approvable letter did not include efficacy data from new clinical trials, which had been requested by FDA. The bumpy regulatory journey for Vasovist (gadofosveset) began before the first approvable letter (1 (Also see "Schering AG/Epix' Imaging Agent Requires Additional Clinical Studies, FDA Says" - Pink Sheet, 14 Jan, 2005.)). After making its original submission in December 2003, the company submitted a reanalysis of the clinical trial data, prompting FDA to extend the original user fee date (2 (Also see "Epix MS-325 User Fee Date Extended" - Pink Sheet, 4 Oct, 2004.)). The issue of a re-read also was anticipated: Epix announced on July 1 that FDA was seeking a re-read of Phase III images. Epix believes that its regulatory difficulties are rooted in a paradigm shift taking place at FDA in the review of imaging agents, with the agency now seeking heavily standardized protocols and broader labels. Epix plans to meet with FDA as soon as possible to discuss the next steps for the application, including design of the requested trial and re-read. The company had been seeking a broad indication for the product based on four Phase III studies in aortoiliac, pedal and renal arteries. Vasovist's recent European approval, based on the same studies, was for "visualization of abdominal or limb vessels in patients with known or suspected vascular disease such as stenosis and aneurysms" in conjunction with magnetic resonance angiography (3 (Also see "Schering AG/Epix Contrast Agent Vasovist Gains EU Approval, Waits For FDA" - Pink Sheet, 5 Oct, 2005.)). Following the second action letter, Epix announced that beginning in the first quarter of 2006 it will reduce its employment levels and research efforts. - John Rancourt |