Posted by Michael Wonder on 08 Feb 2023
Fintepla (fenfluramine) oral solution approved in the EU for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome
8 February 2023 - UCB’s Fintepla (fenfluramine) oral solution has been approved in the European Union 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 European Commission was based on safety and efficacy data from a global, randomised, placebo-controlled Phase 3 clinical trial, in 263 patients with Lennox-Gastaut syndrome (aged 2-35 years), that demonstrated adjunctive fenfluramine at a dose of 0.7/mg/kg/day provided a significantly greater reduction in the frequency of drop seizures (p=0.001) compared to placebo.
