UCB’s Fintepla (fenfluramine) oral solution has been recommended for marketing authorisation in the European Union (EU) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare, severe form of epilepsy.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on safety and efficacy data from a Phase III clinical trial.
The trial demonstrated adjunctive fenfluramine at a dose of 0.7/mg/kg/day provided a significantly greater reduction in the frequency of drop seizures compared to placebo.
The European Commission (EC) will deliver a final decision in Q1 2023.
“This positive CHMP opinion is a significant regulatory milestone towards providing a new treatment option to individuals – and their families – living with this rare epilepsy in the EU,” said Mike Davis, Head of Global Epilepsy & Rare Syndromes, UCB.
Additional data supporting the safety and efficacy of fenfluramine in LGS in the open label extension part of the study was recently published in Epilepsia. It showed that fenfluramine, when added to a patient’s current anti-epileptic treatment, was effective in reducing the frequency of multiple seizure types and was generally well tolerated during a median treatment duration of 364 days.
Fenfluramine is already approved in the US for the treatment of seizures associated with Lennox-Gastaut syndrome. It is also approved for the treatment of seizures associated with Dravet syndrome in the EU, US, and Japan.