Skip to Content


Treatment for Diagnostic

Epix Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist

LEXINGTON, Mass., December 14, 2006 -- EPIX Pharmaceuticals, Inc. today announced that it will submit a formal appeal to the director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) asking the director to overrule the decision by the Office of New Drugs (OND) denying a previously submitted appeal for its novel blood-pool imaging agent Vasovist (gadofosveset trisodium injection). The company anticipates submitting the appeal in the first quarter of 2007.

This appeal is in response to OND's denial in August 2006 of EPIX's appeal to OND of two approvable letters. The decision to appeal from OND to the CDER director was made because EPIX vigorously disagrees with CDER's previous determinations that Vasovist has not been shown to be safe and effective for identifying problematic stenosis in the peripheral vasculature. EPIX also plans to reiterate its request for FDA to convene an advisory committee before deciding on this new appeal. The company believes that where, as here, there is clear-cut scientific disagreement FDA should not refuse a request to allow external experts to provide their independent viewpoints. The time needed for the CDER director to hear the appeal will depend on whether FDA agrees to convene an advisory committee and, if so, how long that process takes.

Andrew Uprichard, M.D., president of EPIX Pharmaceuticals, said, "We are very pleased that regulatory authorities for the European Community, Switzerland, Canada, and Australia have already approved Vasovist for the visualization of peripheral vascular disease. We look forward to approval in the U.S."

About Vasovist

Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography. The initial target indication for Vasovist is for use in magnetic resonance angiography imaging of non-coronary vascular disease. Vasovist has been approved for marketing in 30 countries including all 25 member states of the European Union, Norway, Iceland, Switzerland, Australia and Canada, where it is marketed by Schering AG, Germany.

Related Articles

Ablavar (gadofosveset trisodium) FDA Approval History

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.