Eisai re-submits perampanel NDA; FDA accepts Gilead's Quad

Japanese drug major Eisai (TYO: 4523) says that it has re-submitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the US Food and Drug Administration (FDA) on December 22, 2011.

This re-submission comes after a setback for the company when the FDA issued a Refusal to File letter in the summer in which agency requested reformatting and re-analyses of some datasets in the dossier (The Pharma Letter August 1). The application was originally submitted in May 2011. The FDA will determine acceptance of filing within 60 days of the re-submission, according to Eisai.

Epilepsy is a therapeutic area of focus for Eisai, which says that, by offering multiple treatment options, it seeks to make further contributions to help address the diversified needs of epilepsy patients and their families as part of its corporate human health care mission.