FDA Approves Fintepla for Difficult-to-Treat Seizure Disorder

The FDA has approved UCB’s Fintepla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. The agency also granted pediatric exclusivity for the product. Fintepla is already approved for the treatment of seizures associated with Dravet syndrome in patients two years of age and older in the United States and European Union.

It is available in the United States through a Risk Evaluation and Mitigation Strategy (REMS) Program. Fintepla is serotonergic drug, and there is an association between with these therapies and heart disease that impacts the valve and pulmonary arterial hypertension. Prior to starting treatment, patients must undergo an echocardiogram to establish a baseline prior to initiating treatment and exclude any pre-existing valvular heart disease or pulmonary hypertension. Additionally, echocardiogram monitoring should be conducted every six months for the first two years and annually thereafter.

This approval was based on data from a phase 3 trial in 263 patients with Lennox-Gastaut syndrome (age 2-35 years), which demonstrated that Fintepla reduced the frequency of drop seizures compared with placebo. Drop seizures, also called atonic seizures, causes a sudden loss of muscle strength.

The common adverse reactions that occurred in patients treated with fenfluramine (incidence at least 10% and greater than placebo) were diarrhea; decreased appetite; fatigue; somnolence; vomiting.

Kelly Knupp, M.D.

“LGS is one of the most challenging epileptic encephalopathies to treat, and the vast majority of patients are not well controlled, despite a regimen of multiple antiepileptic drugs,” Kelly Knupp, M.D., associate professor, Children’s Hospital Colorado, said in a press release. “As a complementary therapy, fenfluramine offers a different mechanism of action and demonstrated ability to significantly reduce the number of seizures associated with a drop, a critical measure for managing this severe form of epilepsy.”

Lennox-Gastaut syndrome is a severe childhood-onset epileptic encephalopathy characterized by drug-resistant seizures with high morbidity, as well as serious impairment of neurodevelopmental, cognitive, and motor functions. It affects an estimated 30,000 to 50,000 patients in the United States.

Fintepla was developed by Zogenic, which UCB acquired on March 7, 2022.