EISAI'S INOVELON APPROVED IN EUROPE

Eisai announced that its UK subsidiary received a marketing authorization approval for the antiepileptic agent Inovelon (rufinamide) as adjunctive therapy to treat Lennox-Gastaut Syndrome (LGS) in the European Commission.

Eisai had submitted the marketing authorization application for Inovelon in March 2005 through the centralized procedure. In November 2006 the company received a positive opinion by the Committee for Medicinal Products for Human Use.

Inovelon is a structurally novel compound that acts as a broad-spectrum anticonvulsant. The European approval was based on the result from a double-blind, placebo-controlled, randomized, parallel-group trial that studied the drug's safety and efficacy in the adjunctive treatment of LGS, a severe form of epilepsy that develops in early childhood. As a result of the trial, Inovelon exhibited significant reduction in seizure frequency compared with placebo.

Inovelon was originally discovered and developed by Novartis. Eisai signed an in-licensing agreement for the global rights for the compound in 2004.