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news.Eisai Medical Research has submitted a new drug application to the FDA for its anti-epileptic drug rufinamide. The application seeks approval for the drug to be used to treat two separate forms of the disorder.
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The first indication that the company is seeking approval for is in the treatment of seizures associated with Lennox-Gastaut syndrome, a severe form of epilepsy that develops in early childhood. The FDA granted the drug orphan status for this indication in October 2004.
Rufinamide will also be filed with the FDA as adjunctive therapy in adults and adolescents, 12 years of age and over, with partial-onset seizures. Partial seizures affect only one area of the brain and are the most common type of seizure experienced by people with epilepsy.
“Rufinamide may be an important breakthrough for Lennox-Gastaut syndrome,” said Dr Santiago Arroyo, medical director of CNS at Eisai Medical Research. “LGS is a serious condition that is difficult to manage with currently approved treatments, and the epilepsy community needs new options.”
With the filing of rufinamide, for which Eisai acquired exclusive North American and European manufacturing and marketing rights from Novartis Pharma in 2004, Eisai plans to strengthen its neurology franchise.