Eisai epilepsy drug gains marketing authorisation

Eisai has announced that its UK subsidiary has received marketing authorisation from the European Commission for its anti-epileptic drug, Inovelon (rufinamide). The compound is indicated for use as an adjunctive treatment in patients with Lennox-Gastuat Syndrome (LGS).

Inovelon is a novel compound acting as a broad-spectrum anticonvulsant for the treatment of LGS, with the results of clinical trials showing a reduction in the frequency of seizures in this severe form of epilepsy.

The subsidiary had submitted the application for such authorisation in March 2005 and received a positive opinion from the Committee for Medicinal Products for Human Use in November last year.

“Eisai is currently enhancing its neurology franchise which includes Aricept (donepezil) for the treatment of Alzheimer’s and anti-epilepsy agent Zonegran (zonisamide),” the company reports.

It adds that the market authorisation of Inovelon leads it to forecast that it will make additional contribution in meeting the needs of patients with neurological conditions.

Last year, Eisai claimed that the recommendations by the National Institute for Health and Clinical Excellence and the Social Care Institute for Excellence regarding administration of Aricept marked a “shamefully wasted opportunity” regarding the provision of care to patients with mild forms of Alzheimer’s disease.