Eisai Recieves Positive Opinion for Inovelon® Marketing Authorization from European Committee for Medicinal Products for Human Use (CHMP)
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that on November 16 (U.K. time) the company's UK subsidiary Eisai Ltd. (Headquarters: London, Managing Director: Paul Hooper) received a positive opinion that recommends 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.
[Please see the following note for the product information of Inovelon® submitted to EMEA and the description of LGS]
Corporate Communications Department
Eisai Co., Ltd.
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