Epix submitted the appeal to the FDA’s Office of New Drugs (OND) on June 30, 2006 in response to two prior approvable letters for Vasovist. Epix were also told by the FDA that conducting two new clinical trials would be needed if they were going to secure a third approval and would be safer than using data from a previous clinical trial.
“We are evaluating several options available to us as next steps with Vasovist in the US, including the option to appeal this decision to the next level at the FDA, and will update the market accordingly,” said Andrew Uprichard President of Epix Pharmaceuticals.
Vasovist was approved in the European Union and Switzerland last year. Vasovist has also been recommended for approval in Australia.