Fintepla Treatment Linked to Sustained Seizure Reductions in Lennox-Gastaut Syndrome
KEY TAKEAWAYS
- In a post hoc analysis of patients with Lennox-Gastaut syndrome, seizure reductions were observed after patients switched from placebo to Fintepla (fenfluramine) in the open-label extension.
- Improvements in seizures associated with a fall and global functioning were seen within 1 month and continued as mean Fintepla dose increased.
- Common treatment-emergent adverse events increased after Fintepla initiation but generally decreased over time with continued use.
Post hoc data published in Epilepsia Open showed reductions in seizures associated with a fall and improvements in global functioning among individuals with Lennox-Gastaut syndrome (LGS) treated with Fintepla (fenfluramine; UCB, Brussels, Belgium) in an open-label extension (OLE) of a phase 3 randomized clinical trial (NCT03355209).
The analysis included 151 pediatric and adult participants who completed 12 months of the OLE after participating in the 14-week randomized controlled trial. Participants were grouped according to prior treatment: those who had received placebo in the randomized trial and then started Fintepla in the extension (PBO-FFA; n=59) and those who received Fintepla in both the randomized and extension periods (FFA-FFA; n=92). All patients began the extension at Fintepla 0.2 mg/kg/day, with mean dosing increasing to approximately 0.5 mg/kg/day by month 4 and remaining stable through month 12.
Highlights from the study
- At month 1 of the extension, median reduction in seizures associated with a fall was 32.1% in the PBO-FFA group and 48.5% in the FFA-FFA group.
- From months 4 through 6, reductions were 48.2% in the PBO-FFA group and 44.2% in the FFA-FFA group.
- There was a mean increase in days free of seizures associated with a reduction from months 4 through 6: 6.2 days in the PBO-FFA group and 5.1 days in the FFA-FFA group.
- By month 12, parent/caregiver-rated clinically meaningful global improvement was reported for 52.6% of participnats in the PBO-FFA group and 50.0% in the FFA-FFA group.
- Investigator-rated clinically meaningful improvement at month 12 was reported for 46.3% and 50.5% of participants, respectively.
During the OLE, treatment-emergent adverse events were reported in 86.4% of the PBO-FFA group and 88.0% of the FFA-FFA group. Common events included decreased appetite, somnolence, fatigue, diarrhea, pyrexia, and nasopharyngitis. The authors noted that the analysis was limited to participnats who completed at least 12 months of open-label treatment, used flexible dosing, and did not account for concomitant antiseizure medications. Because the analysis was post hoc.
Sources
Nabbout R, Devinsky O, Lagae L, Scheffer IE, Guerrini R, Sullivan J, et al. Changes in effectiveness and safety in patients with Lennox–Gastaut syndrome transitioning from the fenfluramine randomized controlled trial to open-label extension study. Epilepsia Open. 2026; 00: 1–9. https://doi.org/10.1002/epi4.70320
UCB. Epilepsia Open publishes results of post hoc data analysis of Fintepla (fenfluramine) in patients with Lennox-Gastaut syndrome. PR Newswire. Published August 5, 2026. Accessed August 6, 2026. https://www.prnewswire.com/news-releases/epilepsia-open-publishes-results-of-post-hoc-data-analysis-of-fintepla-fenfluramine-in-patients-with-lennox-gastaut-syndrome-302843865.html