Epix made the submissions after the FDA requested back in January that the company supply additional clinical information in support of a new drug application in magnetic resonance angiography (MRA) to diagnose vascular disease.
Epix’ response did not include efficacy data from new clinical trials, which were requested by the FDA, but it did offer new analyses of existing data, including the manner in which non-contrast comparator scans were performed in the phase III trials.
The FDA said it would now review the Vasovist application, including the new submission, with a view to taking action in late November this year.
Schering AG submitted an application for approval of Vasovist in Europe in June 2004 and is expecting to launch the product late this year. If approved, the company hopes the drug will establish a new class of blood pool contrast agents for MRA to diagnose vascular disease. It is also anticipated to generate peak sales of 100 million euros
“Although we are not yet in agreement with the FDA, we look forward to discussing the scientific issues with them as they review our complete response,” said Michael Webb, CEO of Epix. “During the review process, the FDA could again request additional studies or other information before granting approval for Vasovist.”