Fintepla
Neurology· 592 cited findings· 2 source documents
Company: UCB SA →
What the regulatory reviews say
Fintepla (fenfluramine hydrochloride) is indicated for the treatment of Dravet Syndrome in patients aged 2 years to 17 years and adults. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on 15 October 2020. Fenfluramine was granted orphan medicinal product designation on 18 December 2013.
In efficacy studies, Fintepla demonstrated a 63.9% reduction in baseline-adjusted convulsive seizure frequency (CSF) compared to placebo. The least squares mean CSF per 28 days was 7.9 with Fintepla (0.8 mg/kg/day) versus 21.8 with placebo. Another study showed a 54.0% reduction in monthly CSF with Fintepla (0.5 mg/kg/day) versus placebo. The median monthly frequency of major motor seizures at baseline was 2.5, which decreased to 2.0 during fenfluramine treatment.
Safety findings include a historical association of fenfluramine withdrawal with cardiac valve abnormalities. Adverse events led to withdrawal in 12.5% of patients in the 0.8 mg/kg/day group. The proposed Fintepla dose range is 0.2 to 0.7 mg/kg/day, with a maximum total daily dose of 26 mg. When co-administered with stiripentol, the maximum daily dose is 0.4 mg/kg/day, with a maximum total daily dose of 17 mg.
Key figures — cited to the source page
| Percent difference in baseline-adjusted CSF reduction | 63.9 | UCB SA — Fintepla EMA EPAR public assessment report (EMEA/H/, p.54 |
| Least squares mean CSF per 28 days (ZX008 0.8 mg/kg/day) | 7.9 | UCB SA — Fintepla EMA EPAR public assessment report (EMEA/H/, p.54 |
| Least squares mean CSF per 28 days (placebo) | 21.8 | UCB SA — Fintepla EMA EPAR public assessment report (EMEA/H/, p.54 |
| Reduction in monthly CSF (ZX008 0.5 mg/kg/day vs placebo) | 54.0 | UCB SA — Fintepla EMA EPAR public assessment report (EMEA/H/, p.60 |
| Median monthly frequency of major motor seizures at baseline (Study ZXIIS2015-004) | 2.5 | UCB SA — Fintepla EMA EPAR public assessment report (EMEA/H/, p.41 |
| Median monthly frequency of motor seizures during fenfluramine treatment (Study ZXIIS2015-004) | 2.0 | UCB SA — Fintepla EMA EPAR public assessment report (EMEA/H/, p.41 |
| AEs leading to withdrawal (ZX008 0.8 mg/kg/day group) | 12.5 | UCB SA — Fintepla EMA EPAR public assessment report (EMEA/H/, p.51 |
| CHMP positive opinion date | 15 October 2020 | UCB SA — Fintepla EMA EPAR public assessment report (EMEA/H/, p.11 |
Source documents
Explore the full evidence
All 592 cited findings for Fintepla — searchable, comparable and answerable in plain language — are in the Neurology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.