UCB, a global biopharmaceutical company, has announced the final results from its open-label extension (OLE) study evaluating Fintepla (fenfluramine) for the treatment of Lennox–Gastaut syndrome (LGS).
The findings, published in Epilepsy & Behaviour, showed that Fintepla produced a clinically meaningful and sustained reduction in the frequency of seizures involving a fall (drop seizures) in patients aged from two to 35 years of age. Reductions were observed from the second month of treatment and maintained through to the end of the study compared with baseline levels.
Both caregivers and investigators reported improvements in overall functioning, including enhanced social interactions, mental health and quality of life. No new or unexpected treatment-emergent adverse events were identified during the study.
These results build on earlier data from a similar OLE study published earlier this year that assessed the long-term safety and efficacy of Fintepla in patients with Dravet syndrome. That study also demonstrated a sustained reduction in monthly convulsive seizure frequency and consistent long-term tolerability.
Kelly G Knupp, associate professor of Pediatrics and Neurology at the CU Anschutz School of Medicine, and coauthor of the paper, said, “This data reinforce the long-term safety and tolerability of fenfluramine in children and adults living with LGS, a condition with a significant unmet medical need. The sustained reduction in seizure frequency, coupled with the meaningful improvements in quality of life for both patients and their families, underscores the importance of addressing not just the clinical but also the emotional and social challenges faced by these families every day.”
LGS is a rare and severe developmental and epileptic encephalopathy characterised by tonic seizures, at least one other seizure type and significant developmental delays. Typically presenting in early childhood, LGS can persist into adulthood and is associated with cognitive impairment, psychiatric symptoms and behavioural and mobility challenges. The condition remains largely drug-resistant despite current treatment options.