EMERYVILLE, Calif. – Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies today announced the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the company’s supplemental New Drug Application (sNDA) for the use of FINTEPLA® for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS). The FDA granted Priority Review, which means that the FDA has a goal to complete its review within six months from the date of receipt, with a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2022. FDA Priority Review is granted for investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.
“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, Ph.D., 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.”
The sNDA submission is based on a positive, global, randomized, placebo-controlled Phase 3 clinical trial, Study 1601, in 263 patients (age 2-35 years) that demonstrated FINTEPLA at a dose of 0.7/mg/kg/day was superior to placebo in reducing the frequency of drop seizures (p=0.0012), as well as long-term safety and effectiveness data from Zogenix’s ongoing open-label extension trials.
In June 2020, FINTEPLA was approved by the FDA for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.
About Lennox-Gastaut Syndrome
Lennox-Gastaut Syndrome (LGS) is a rare and devastating lifelong childhood-onset epilepsy that can arise from multiple different causes. LGS is characterized by many different seizure types, including many that result in frequent falls and injuries and that often don’t respond to currently available seizure medications. The intellectual and behavioral problems associated with LGS, as well as around-the-clock care requirements, add to the complexity of life with this disease. There are an estimated 30,000 to 50,000 people who have LGS in the United States.
Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company’s first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, has been approved by the U.S. FDA for the treatment of seizures associated with Dravet syndrome in patients two years of age and older and the European Medicines Agency for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. In the U.S. and Europe, treatment with FINTEPLA is initiated and supervised by physicians with experience in the treatment of Dravet syndrome under a Risk Evaluation Mitigation Strategy (REMS) program (U.S.) or Controlled Access Program (EU). In the United States, please see important prescribing and safety information at www.Fintepla.com. In Europe, please see important prescribing and safety information at www.Fintepla.eu.
In Japan, Zogenix is on track to submit a new drug application (J-NDA) for FINTEPLA for the treatment of seizures associated with Dravet syndrome in late 2021. The company has two additional late-stage development programs: one in a rare epilepsy called Lennox-Gastaut syndrome and one in a mitochondrial disease called TK2 deficiency. Zogenix also plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.
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