FDA Accepts Priority Review Application for Fenfluramine for Lennox-Gastaut Seizures

The Food and Drug Administration (FDA) has accepted for filing and granted priority review to a supplemental New Drug Application (sNDA) for the use of fenfluramine (Fintepla; Zogenix, Emeryville, CA) for seizures associated with Lennox-Gastaut syndrome (LGS). The FDA granted priority review with a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2022. 

The sNDA submission is based on a global randomized placebo-controlled phase 3 clinical trial, Study 1601 (NCT03355209). In study 1601 of 263 participants age 2 to 35 years, fenfluramine (0.7/mg/kg/day) was superior to placebo in reducing the frequency of drop seizures (P=.0012). Long-term safety and effectiveness data from the ongoing open-label extension trials also support the sNDA.

“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,” said Gail Farfel, PhD, executive vice president and chief development officer of Zogenix. “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.”

In June 2020, fenfluramine was approved by the FDA for the treatment of seizures associated with Dravet syndrome in individuals ages 2 years and more.