Final results from open-label extension confirm sustained safety and effectiveness
UCB today announced the publication of final results from its open-label extension (OLE) study evaluating FINTEPLA® (fenfluramine) for the treatment of Lennox-Gastaut syndrome (LGS) in Epilepsy & Behavior. The study demonstrated sustained seizure reduction, consistent safety, and improvements in global functioning and caregiver well-being over 12 months of follow-up.
FINTEPLA is already approved by the U.S. FDA for the treatment of seizures associated with Dravet syndrome (DS) and LGS in patients aged two years and older.
“These data reinforce FINTEPLA’s long-term safety and meaningful impact on both patients and families. The sustained seizure reduction alongside emotional and social improvements is a critical step for the LGS community.”
LGS is a rare, severe developmental and epileptic encephalopathy that typically begins in childhood and persists into adulthood. It involves multiple seizure types—most notably tonic and drop seizures—and leads to significant cognitive, behavioral, and physical impairment. Seizures often remain resistant to currently available medications, and the risk of SUDEP (sudden unexpected death in epilepsy) remains high.
FINTEPLA® is a prescription antiepileptic drug approved for seizures associated with Dravet syndrome and LGS in patients aged two years and older.
Boxed Warning: FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension; echocardiogram monitoring is required before, during, and after treatment. The drug is available only through the FINTEPLA REMS program.
Other key warnings include:
UCB is a global biopharmaceutical company focused on the discovery and development of innovative treatments for people living with severe neurological and immunological disorders.