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news.Eisai has received marketing authorization from the European Commission for the anti-epileptic agent Inovelon, indicated as adjunctive therapy in Lennox-Gastaut Syndrome.
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Eisai submitted the marketing authorization application for Inovelon in March 2005 to the European Medicines Agency. The drug has also received orphan status in the EU.
Inovelon is a structurally novel compound that acts as a broad-spectrum anticonvulsant. The data used for approval by EC this time was based on the result from a clinical trial, which studied the drug’s safety and efficacy in adjunctive treatment of Lennox-Gastaut Syndrome (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 to the placebo.
Eisai is currently enhancing its neurology franchise which includes Aricept for treatment of Alzheimer’s disease and anti-epilepsy agent Zonegran.
Inovelon was originally discovered and developed by Novartis. Eisai signed an in-licensing agreement for the global rights of the compound with Novartis in February 2004.