Fintepla reduces the frequency of seizures in Dravet patients: Study

Therapy is associated with 5+ times higher chance of 50% decline in symptoms

Andrea Lobo, PhD avatar

by Andrea Lobo, PhD |

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Adding Fintepla (fenfluramine) to anti-seizure treatment is associated with a more than five times higher chance of having a 50% decline in the frequency of Dravet syndrome-related seizures, a review of clinical trial data shows,

Decreased appetite, diarrhea, fatigue, and weight loss were among the noncardiovascular side effects associated with Fintepla.

The findings add to previous real-world data that support Fintepla as an effective add-on therapy for Dravet patients, without cardiovascular side effects.

The study, “Efficacy and Safety of Fenfluramine in Epilepsy: A Systematic Review and Meta-analysis,” was published in Neurology and Therapy.

Dravet syndrome is a rare type of epilepsy that features episodes of prolonged seizures that begin in the first year of life. Current treatment strategies are based on using multiple anti-seizure medications of different classes and with distinct mechanisms of action.

UCB’s Fintepla, a low-dose fenfluramine oral solution, is approved in the U.S.Europe, and Japan as an add-on treatment to reduce seizures in patients, 2 and older. It’s also approved for Lennox–Gastaut syndrome (LGS), another severe form of childhood epilepsy, for the same ages.

Researchers in Italy and Austria retrospectively analyzed data published up to June 2022 from appropriately controlled clinical trials that tested Fintepla in patients with uncontrolled seizures despite medication to synthesize the evidence regarding its efficacy and safety with Dravet and LGS.

“This could allow us to appreciate the effects of [Fintepla] across different epileptic syndromes and assess the tolerability profile based on a larger population dataset,” the researchers wrote.

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Fintepla’s safety, effectiveness assessed

They identified three studies of four Phase 3 trials for the meta-analysis. They all assessed Fintepla’s effectiveness or safety against a placebo, administered twice a day in addition to an existing anti-seizure treatment regimen.

Two of the studies, a merger between a North American trial (NCT02682927) and Western European and Australian trial (NCT02682927) and an international trial (NCT02926898) included 206 Dravet patients, ages 2-18. The remaining trial (NCT03355209) involved 263 LGS patients, ages 2-35.

A total of 128 patients received 0.2 mg/kg/day of Fintepla, 43 were given 0.5 mg/kg/day, 127 received 0.8mg/kg/day, and 171 were given a placebo.

The Dravet patients treated with Fintepla had a more than five times greater chance of achieving at least a 50% reduction in the monthly frequency of convulsive seizures relative to the start of the study than those on a placebo.

A drop of at least 50% in the frequency of seizures occurred in 53.3% of the Fintepla-treated Dravet patients compared with 8.3% of those given a placebo — a statistically significant difference.

Dravet patients given add-on Fintepla were also 13 times more likely to achieve near seizure freedom (less than one seizure per month) than the placebo group. Fintepla was also linked to a nearly five times greater chance of becoming seizure free relative to a placebo, but this result didn’t reach statistical significance.

Near seizure freedom was reached by 16.4% of the patients receiving Fintepla and none on a placebo, corresponding to a 13.43 higher chance of being seizure-free. Specifically, near seizure freedom was reached by 16.4% of Fintepla-treated patients and none in the placebo group.

The mean difference in the longest seizure-free interval was 15.4 days between the 0.2 mg/kg/day Fintepla and placebo groups, 16.3 days between the 0.5 mg/kg/day and placebo groups, and 22.3 days between the 0.8 mg/kg/day and placebo groups.

Similar efficacy results were seen among the LGS patients.

Across the trials, a significantly greater proportion of patients on Fintepla versus those on a placebo were reported to have much or very much improved on the Clinical Global Impression-Improvement scale by their caregiver (35.5% vs. 10.3%) and site investigators (34.1% vs. 9.8%).

Side effects of Fintepla

A greater proportion of Fintepla-treated patients discontinued treatment relative to those on a placebo (10.1% vs. 5.8%) and did so more often due to side effects (5.4% vs. 1.2%). These differences didn’t reach statistical significance, however.

There were also no significant group differences in the proportion of patients having side effects (88.6% with Fintepla vs. 77.8% with a placebo) and serious side effects (9.7% vs. 8.8%).

Compared with a placebo, Fintepla was significantly associated with decreased appetite (30.5% vs. 9.9%), diarrhea (16.8% vs. 5.8%), weight loss (10.4% vs. 2.9%), and fatigue (14.4% vs. 7%). Other side effects were low blood glucose, bronchitis, fever, seizures, somnolence, vomiting, and upper respiratory tract infections.

Despite Fintepla’s association with serious side effects such as valvular heart disease and pulmonary arterial hypertension, none were reported during the trials, supporting its cardiovascular safety.

These finding indicate Fintepla “may provide a new treatment option for patients with these epileptic and developmental [diseases],” the researchers wrote, adding more research is needed to study Fintepla’s clinical activity in “other epileptic conditions and its potential to reduce the risk of sudden unexpected death in epilepsy.”