UCB’s Fintepla (fenfluramine) oral solution has been approved in the European Union (EU) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).
It has received authorisation as an add-on therapy to other anti-epileptic medicines for patients two years of age and older.
The approval was based on safety and efficacy data from a global, randomised, placebo-controlled Phase III clinical trial in 263 patients with LGS (aged 2-35 years).
Professor Rima Nabbout, Professor of Paediatric Neurology at University Paris cité, APHP, Necker Enfants Malades, Institut Imagine, Paris, France, said: “LGS is a developmental and epileptic encephalopathy where seizures are frequent, inducing high level of trauma injuries and negatively impacting development and quality of life. Seizures are often resistant to currently available medications, making this approval especially important for the individuals affected and their families.”
The EC has also adopted the EMA Committee for Orphan Medicinal Products (COMP) recommendation that the orphan designation for fenfluramine be maintained.
LGS is a severe childhood-onset developmental and epileptic encephalopathy (DEE) characterised by multiple types of drug-resistant seizures with high morbidity, as well as serious impairment of neurodevelopmental, cognitive, and motor functions, affecting an estimated two in 10,000 people in the EU.