CHMP recommends Fintepla for the treatment of seizures associated with Dravet syndrome.- Zogenix

Zogenix announced that the Committee for Medicinal Products for Human Use (CHMP), a part of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of Fintepla (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome, a rare and devastating infant- and childhood onset epilepsy, as an add-on therapy to other antiepileptic medicines for patients two years of age and older. The European Commission (EC) is expected to make a final decision on the company’s Marketing Authorization Application (MAA) by the end of the year. The MAA for Fintepla included positive results from two randomized, controlled Phase III trials (Study 1 and Study 2), together with an interim analysis of an ongoing long-term, open-label extension study involving a total of 330 Dravet syndrome patients. These studies demonstrated that adjunctive fenfluramine treatment provided a highly statistically significant and clinically meaningful reduction in convulsive seizure frequency compared to placebo and was generally well-tolerated. In one of the trials, Study 2, all subjects were treated with a background regimen that included stiripentol, with significant improvement observed for Fintepla over placebo. The long-term, open-label extension study demonstrated durable efficacy, with patients in that study treated for up to three years with Fintepla. The most commonly reported adverse events experienced during these studies were decreased appetite, diarrhea, pyrexia, fatigue, upper respiratory tract infection, lethargy, somnolence and bronchitis. No patient developed any cardiovascular adverse events, including valvular heart disease or pulmonary arterial hypertension.