Pharma Focus Asia

FINTEPLA[®] (fenfluramine) Oral Solution Approved in the EU

Thursday, February 09, 2023

UCB’s FINTEPLA® (fenfluramine) oral solution approved in the European Union (EU) 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.

LGS is a developmental and epileptic encephalopathy where seizures are frequent, inducing high level of trauma injuries which negatively impacts development and quality of life. Seizures are often resistant to currently available medications, making the approval especially important for the individuals affected and families.

Fenfluramine is now an important additional treatment option for those impacted by this difficult to treat condition in Europe. This approval improves treatment outcomes, by addressing the high unmet need for new treatments for people living with LGS and rare epilepsies.

Fenfluramine is a serotonin releasing agent, and stimulating multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine reduces seizures by acting as an agonist at specific serotonin receptors in the brain, including the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sigma-1 receptor. The precise mode of action of fenfluramine in Dravet syndrome and Lennox-Gastaut syndrome is not known.

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