FINTEPLA (fenfluramine) oral solution approved in Japan for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
Fintpla (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 (LGS) 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 randomized Phase III clinical trial (1601 Study Cohort A & B), in 296 patients with LGS (aged 2-35 years), including 33 in Japan. In the Japanese sub-population, adjunctive fenfluramine, at a dose of 0.7 mg/kg/day, provided a greater reduction in the frequency of drop seizures compared to placebo. The most common ( greater than 10%) non-cardiovascular treatment–emergent adverse events (TEAEs) were decreased appetite, somnolence, weight decreased, diarrhea, and nasopharyngitis. No cases of valvular heart disease or pulmonary arterial hypertension were observed.
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