Fintempla (fenfluramine) oral solution approved in Japan for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome

UCB

17 April 2024 - – UCB’s Fintempla (fenfluramine) oral solution has been approved by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for the treatment of seizures associated with Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients two years of age and older.

The approval by the MHLW was based on safety and efficacy data from a global, double-blind, placebo-controlled, parallel-group randomised Phase 3 clinical trial (1601 Study Cohort A & B), in 296 patients with LGS (aged 2-35 years), including 33 in Japan.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , Japan