This appeal is in response to the Office of New Drugs denial in August 2006 of Epix’s appeal of two approvable letters. The decision to appeal was made because Epix disagrees with 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. Epix anticipates submitting the appeal in the first quarter of 2007. The appeal will be submitted to the director of the Center for Drug Evaluation and Research at the FDA.
Vasovist has already been approved in the European Community, Switzerland, Canada, and Australia.