Eisai's Inovelon approved for LGS in EU

Japanese drugmaker Eisai has received a Marketing Authorization approval for its anti-epileptic agent Inovelon (rufinamide) for adjunctive therapy in Lennox-Gastaut syndrome from the European Commission.

Eisai's UK unit submitted the application in March 2005 to the European Medicines Agency (EMEA) through the centralized procedure. In November 2006, the company received a positive opinion by the Committee for Medical Products for Human Use, which led to the approval of the drug by the EC.

Inovelon is a structurally-novel compound that acts as a broad-spectrum anticonvulsant. The data used for approval by the EC was based on the results of a clinical, double-blind, placebo-controlled, randomized, parallel-group trial that studied the drug's safety and efficacy in adjunctive treatment of LGS, a severe form of epilepsy that develops in early childhood. Inovelon patients exhibited significant reduction in seizure frequency versus placebo, Eisai noted.