FDA Approves Drug for Dravet Syndrome
The US Food and Drug Administration (FDA) has approved Fintepla (fenfluramine) to treat seizures associated with Dravet syndrome–a chronic, rare, and life-threatening form of epilepsy–among patients aged 2 years or older.
A Schedule IV controlled substance, fenfluramine was approved following the completion of 2 clinical studies (N = 202) of individuals with Dravet syndrome aged 2 to 18 years. The results of both studies indicated that reductions in the frequency of convulsive seizures during the trial period had been significantly greater among Fintepla-treated participants compared with those who received placebo.
“Dravet syndrome is a debilitating disease that takes a tremendous toll on both patients and their families,” said Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, in a press release. “Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome. The FDA will continue to work with companies on drug development for Dravet syndrome and other types of epilepsy,” Dr Dunn added.
A boxed warning included on Fintepla labeling indicates that Fintepla is associated with valvular heart disease and pulmonary arterial hypertension. Because of these risks, Fintepla is can only be accessed through a restricted drug distribution program as part of a risk evaluation and mitigation strategy, the FDA noted.
FDA approves new therapy for Dravet syndrome. News release. US Food and Drug Administration. June 25, 2020. Accessed June 26, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-dravet-syndrome