FDA has called on Epix Pharmaceuticals to conduct two additional clinical trials before the agency considers approving the blood clot imaging agent Vasovist (gadofosveset), the company announced Aug. 28.

The suggestion is included in an Office of New Drugs letter denying Epix' appeal of two "approvable" letters for Vasovist. In its June 30 appeal, the company requested a meeting before the Cardiovascular & Renal Drugs Advisory Committee to make its case (¹ Also see "Epix Launches Appeal For FDA Approval Of Vasovist" - Pink Sheet, 6 July, 2006.).

Epix had hoped that either the committee meeting or a blinded re-read of previously submitted data would convince the agency to approve the product.

The company is now actively mulling raising its appeal to the Center for Drug Evaluation & Research level.

During an Aug. 23 investors call, Epix President Andrew Uprichard said the company "would appeal one level higher at the FDA" if an OND appeal failed (² Also see "Vasovist Approval Strategy: Another Appeal, Not Another Trial" - Pink Sheet, 23 August, 2006.).

Epix also downplayed the idea of conducting additional trials because they would not guarantee that Vasovist would ultimately gain FDA approval.

The company told "The Pink Sheet" DAILY that support for Vasovist's approval is grounded in 18 clinical trials involving more than 1,400 patients. The product is approved in the European Union and Switzerland, and received a favorable recommendation in Australia, Epix noted (³ Also see "Schering AG/Epix Contrast Agent Vasovist Gains EU Approval, Waits For FDA" - Pink Sheet, 5 October, 2005.).

Epix added that a decision on whether to raise the level of its appeal would come "sooner rather than later;" the company remains committed to bringing Vasovist to market.

- Jonathan Block (j.block@elsevier.com)

FDA Denies Epix Appeal, Asks For New Vasovist Trials

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