Eisai Submits New Drug Application for the Anti-epileptic Agent Rufinamide in the United States
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced that on September 8, 2005 (US Eastern Time), its U.S. subsidiary, Eisai Medical Research Inc. (Headquarters: New Jersey, President: Mindell Seidlin, M.D.), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the anti-epileptic agent rufinamide as adjunctive treatment of partial-onset seizures in adult and adolescent patients (12 years and older) and adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in children (4 years and older).
Rufinamide, a structurally novel compound unrelated to currently marketed anti-epileptic drugs, is a broad-spectrum anticonvulsant discovered and developed by Novartis. Eisai signed an in-licensing agreement for rufinamide with Novartis Pharma AG in February 2004. In Europe, a Marketing Authorization Application was submitted to the European Medicines Agency (EMEA) through the European Union's Centralized Procedure for adjunct therapy for LGS in March 2005.
In the U.S., rufinamide was granted orphan drug designation for the treatment of LGS by the FDA in October, 2004. In addition, data from clinical trials for rufinamide in the treatment of inadequately controlled partial seizures in adults were positive. Consequently, Eisai Medical Research Inc. submitted an NDA for these indications.
With the submission, Eisai aims to strengthen its neurology franchise, which currently includes Aricept, for the treatment of mild to moderate Alzheimer's disease, and Zonegran, an anti-epileptic agent, to fulfill patients' unmet needs and contribute to increasing their benefits.
Corporate Communications Department
Eisai Co., Ltd.
[Product summary of rufinamide submitted to FDA, and explanation of LGS follow]
<Note to the editor>
[Product summary of rufinamide submitted to FDA]