Fintepla safely reduces seizures in children younger than 2, study finds

Five very young patients given therapy for about 1 year in off-label study

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Treatment with Fintepla (fenfluramine) appeared to be reasonably safe and to effectively lower seizure frequency in five young children with Dravet syndrome who started on the therapy before they were 2 years old, scientists in Italy reported.

These findings are especially noteworthy because, in the U.S. and European Union (EU), Fintepla is approved for Dravet patients ages 2 and older. The oral therapy is indicated as an add-on treatment to help control seizures in people with Dravet

The report, “Fenfluramine below the age of 2 years in Dravet Syndrome: what about safety and efficacy?,” which was published as a brief communication in Epilepsia.

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Two treated children saw a more than 50% drop in seizure frequency

“We demonstrated that [Fintepla] used in patients younger than 2 years may offer an excellent tolerability and a clinically significant reductions in seizure frequency,” the researchers wrote.

The five children started with Fintepla between the ages of 9 months and 19 months (about 1.5 years) as part of a study of the treatment’s off-label use. All were using other anti-seizure medications, including Depacon (sodium valproate) and Onfi (clobazam).

They were followed a median of 13 months after starting on Fintepla, and no notable safety concerns were seen. Two children had a reduction in appetite due to Fintepla, but no other side effects were noted, and clinical tests didn’t show any concerns.

Data also indicated that Fintepla helped control seizures: In the six months before starting on the medication, their median monthly convulsive seizure rate was 1.71 seizures/month. While on Fintepla, this rate decreased to 0.92 seizures/month, with two patients reporting a more than 50% drop in seizure frequency.

Measures of cognitive development were generally stable over the course of follow-up. The researchers highlighted that two of the children showed slight improvements in some measures of cognitive development after starting on Fintepla, in contrast to Dravet’s typical progression, where cognitive development slows.

Though the scientists stressed that it’s too early to make definitive conclusions, they said their study offers hope that reducing seizures in early life may help to protect cognitive development over time. This study, despite its small size and lack of an untreated control group, provides some evidence that Fintepla may be safely used to manage seizures in very young children with Dravet syndrome.

“Given preclinical evidence of a possible disease-modifying effect and the safety of [Fintepla’s use in children] … <2 years documented in our study, we suggest early use of [Fintepla]” in patients with Dravet syndrome, the scientists concluded.

This study was funded by the Italian Ministry of Health. UCB, the company that markets Fintepla, was not directly involved.