MRI contrast developer Epix Pharmaceuticals has received a second approvable letter from the Food and Drug Administration (FDA) regarding its Vasovist blood-pool contrast agent.
In this letter, the FDA has indicated that at least one additional clinical trial, and a reread of images obtained in certain of the previously completed phase III trials, will be necessary before it could approve Vasovist, according to Epix of Cambridge, MA. Epix said that it believes these studies would require a substantial period of time to complete.
Epix said it's working with outside regulatory and clinical consultants, and intends to talk with the FDA as it determines its next steps. While believing that Vasovist will ultimately be approved by the FDA, the company has also decided to substantially reduce its research efforts and employment levels, which will be handled in the first quarter of 2006, said interim CEO Michael Astrue.
These changes will allow Epix to focus on advancing its two lead products and highest priority research within its MRI franchise as the company seeks to acquire a therapeutics company as early as possible next year, Astrue said.
By AuntMinnie.com staff writers
November 23, 2005
Related Reading
Schering, Epix score European approval for Vasovist, October 5, 2005
Webb steps down at Epix, September 15, 2005
Epix sales fall, net loss grows, July 28, 2005
Epix makes management moves, July 6, 2005
Epix's Vasovist moves closer to market, July 1, 2005
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