In a press release on December 1, 2021, the manufacturer, Zogenix, announced that the FDA accepted the supplemental New Drug Application (sNDA) for Priority Review of fenfluramine for treating seizures associated with Lennox-Gastaut syndrome (LGS).
The sNDA submission is based on data from a global randomized, placebo-controlled phase lll trial that compared the efficacy and safety of fenfluramine with placebo in 263 patients aged 2 to 35 years with LGS. The data demonstrated that treatment with fenfluramine 0.7 mg/kg/day met the primary endpoint, demonstrating superior reductions in the frequency of drop seizures compared with placebo (P = .0012). A statistically significant improvement in the percentage of patients with a clinically meaningful decrease (50% or greater) in drop seizure frequency (secondary efficacy endpoint) was also observed with fenfluramine.
The sNDA also includes long-term safety and efficacy data from ongoing open-label extension trials. The safety profile of fenfluramine was found to be consistent with that observed in previous studies for Dravet syndrome. A Prescription Drug User Fee Act target date of March 25, 2022, has been set for the application.
Fenfluramine, a schedule IV controlled substance, is marketed under the brand-name Fintepla and is approved for the treatment of seizures associated with Dravet syndrome. The product is available as a cherry-flavored oral solution containing 2.2 mg/mL of fenfluramine.
In the press release, Gail Farfel, PhD, executive vice president and chief development officer of Zogenix, stated, "This is a critically important milestone for our Fintepla development program in LGS and brings us one step closer to a potential new treatment option for this rare and difficult to treat childhood developmental and epileptic encephalopathy. We look forward to working closely with the FDA to potentially bring Fintepla for the treatment of seizures associated with LGS to market as quickly as possible."
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