Eisai Co. of Japan, through its UK-based subsidiary, has received a marketing approval of the anti-epileptic agent Inovelon (Rufinamide) for adjunctive therapy in Lennox-Gastaut Syndrome (LGS) from the Committee for Medicinal Products for Human Use (CHMP), the scientific body of the European Medicines Evaluation Agency (EMEA).
Inovelon has been shown to be effective in the treatment of seizures associated with LGS, a severe form of epilepsy that develops in early childhood. The positive opinion by the CHMP was announced in response to the marketing authorization application submitted by Eisai in March 2005 for an approval of Inovelon for adjunctive therapy of LGS through the European Union's centralized procedure. Inovelon was also granted orphan drug status by the European Commission in October 2004.
Eisai is currently enhancing its neurology franchise, which includes Aricept (donepezil) for treatment of Alzheimer's disease and anti-epilepsy agent Zonegran (zonisamide). Through these activities the company expects to make further contributions in fulfilling the needs of patients and improving benefits to patients and their families.
Inovelon is a structurally novel compound that acts as a broad-spectrum anticonvulsant originally discovered and developed by Novartis Pharma AG. Eisai had signed an in-licensing agreement for the compound with Novartis in February 2004.