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Eisai rufinamide NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Eisai is seeking two indications for its anti-epileptic rufinamide: adjunctive therapy for Lennox-Gastaut syndrome in children ages four and up and adjunctive therapy for partial-onset seizures with and without secondary generalization in adults and adolescents ages 12 and over. The firm submitted the NDA for the triazole derivative Sept. 9, putting a standard review deadline at July 9, 2006. The two pivotal trials supporting the indications were conducted by innovator Novartis. Rufinamide is "structurally distinct from currently approved [anti-epileptic drugs]," Eisai notes. The agent was granted orphan status for Lennox-Gastaut in October 2004...
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