CHMP in favor of Eisai's Inovelon for LGS
Japanese drugmaker Eisai says that its UK subsidiary has received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use, recommending approval of its anti-epileptic Inovelon (rufianmide) as an adjunctive therapy for Lennox-Gastaut Syndrome (LGS).
Eisai explained that the agent has been shown to be effective in controlling the seizures associated with this severe form of childhood epilepsy.
The Tokyo-headquartered firm originally submitted a Marketing Authorization Application to the EMEA early last year (Marketletter April 11, 2005) following the agency's decision to award the product Orphan Drug designation for the adjunctive treatment of LGS.
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