FDA approves Fintepla for treatment of Dravet Syndrome

June 29, 2020

The US Food and Drug Administration (FDA) approves Fintepla (fenfluramine) through Priority Review.

The US Food and Drug Administration has approved Fintepla (fenfluramine) from Zogenix, Inc., which is a Schedule IV controlled substance, for treating seizures associated with Dravet syndrome in children aged 2 and older.1 Seizures in children with Dravet Syndrome are often severe, even with medical treatment.

Two studies were used to show the efficacy of the drug on treating seizures. The studies included 202 participants aged 2 to 18 and both examined the change from baseline in the frequency of convulsive seizures. Participants treated with fenfluramine were found to have greater reductions in the frequency of seizures than the participants who were given a placebo. The reduction was frequently seen by 3 to 4 weeks of treatment and mostly consistent over a 14- to 15-week treatment cycle.

The drug will be required to have a boxed warning that says fenfluramine is linked to both valvular heart disease (VHD) and pulmonary arterial hypertension (PAH). Due to the risks, children who are prescribed the drug must have cardiac monitoring via echocardiograms performed before treatment, at a 6-month interval during the course of treatment, and once every 3 to 6 months after treatment. If VHD, PAH, or any other cardiac abnormality is seen, the risks and benefits of the drug must be considered. Due to the cardiac risks, the drug is only available under a risk evaluation and mitigation strategy (REMS). The plan requires both the health care professionals and the pharmacies dispensing the drug to be specially certified in the REMS. Patients must also be enrolled in it.

In addition to the risk of VHD and PAH, common adverse reactions found in the clinical study included drowsiness, constipation, decreased appetite, ataxia, gait disturbance, fatigue, diarrhea, increased blood pressure, drooling, fever, vomiting, status epilepticus, risk of falls, and upper respiratory tract infection.

The application was granted Priority Review. Fintepla was given an Orphan Drug designation.

Reference:

1. US Food and Drug Administration. FDA approves new therapy for Dravet syndrome. US Food and Drug Administration. Published June 25, 2020. Accessed June 29, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-dravet-syndrome