A Medical Device Daily
EPIX Pharmaceuticals (Lexington, Massachusetts), is appealing an appeal.
It said it will submit a request to the director of the FDA's Center for Drug Evaluation and Research (CDER), 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). Epix said it expects to submit the appeal request next quarter.
This request is in response to the OND's denial in August of EPIX's appeal to OND of two approvable letters (Medical Device Daily, 2006). The company said it “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. It said it also plans to make another request 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,“ it said in a statement.
Andrew Uprichard, MD, president of EPIX, 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.“
Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography, the initial target for its use. It has been market-cleared in 30 countries, including all member states of the European Union, Norway, Iceland, Switzerland, Australia and Canada, where it is marketed by Schering (Munich, Germany).