Schering and Epix get FDA approval for Vasovist

US-based Epix Pharmacuticals have announced that the Food and Drug Administration (FDA) has sent the latter company a second approvable letter for Vasovist.

The drug, developed with German firm Schering, is a blood-pool contrasting agent which can be used in an MRA scan to detect and diagnose vascular disease. The FDA said that an additional clinical trial was required, as well as a re-assessment of images obtained in the phase III trials, before it would approve the agent.

This is the second approvable letter from the FDA for Vasovist. The agency had previously sent Epix a letter in January 2005, after it had made a new drug application in May 2003. Vasovist is already approved for use within the EU.

“While we are disappointed that the FDA did not approve Vasovist at this time, we continue to believe that Vasovist will be an important drug that will be approved by the FDA,” said Michael J Astrue, Epix’s interim CEO.

Mr Astrue said that the announcement would affect the structure of the company, adding that “we have decided that we will have to reduce substantially our research efforts and our employment levels, which we will do in the first quarter of next year.”

He concluded by saying that the company will concentrate efforts on its two “leading products” and high priority MRI research.

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