Benzinga | Dec 20, 2021 08:06AM EST

Zogenix Submits Type II Variation Application To The European Medicines Agency To Expand The Use Of FINTEPLA For The Treatment Of Seizures Associated With Lennox-Gastaut Syndrome

Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that it has submitted its Type II Variation Market Authorization Application to the European Medicines Agency (EMA) for FINTEPLA(r) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a highly treatment-resistant form of childhood-onset epilepsy. If approved, the application would expand the use of FINTEPLA in Europe beyond Dravet syndrome to include LGS.



"The submission of this Type II Variation is a significant milestone for our FINTEPLA program and furthers our goal of bringing FINTEPLA to LGS patients and families in need," said Gail Farfel, Ph.D., Executive Vice President and Chief Development Officer of Zogenix. "We remain focused on working with the EMA to bring FINTEPLA for the treatment of seizures associated with LGS to market as quickly as possible in Europe."

The EMA submission for FINTEPLA is supported by data from a 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). The same dose of FINTEPLA (0.7 mg/kg/day) also demonstrated statistically significant improvement versus placebo in the key secondary efficacy measure, the proportion of patients with a clinically meaningful reduction (?50%) in drop seizure frequency. The submission also includes long-term safety and effectiveness data from Zogenix's on-going open-label extension trials. FINTEPLA has been generally well-tolerated, with the adverse events observed to date consistent with those observed in the Company's prior Phase 3 studies in Dravet syndrome.

In December 2021, the U.S. Food and Drug Administration (FDA) accepted Zogenix's supplemental New Drug Application (sNDA) and granted Priority Review for FINTEPLA for the treatment of seizures associated with LGS. FINTEPLA is approved by the FDA and European Commission for the treatment of seizures associated with Dravet syndrome, a rare infant- and childhood-onset epilepsy marked by frequent and severe treatment-resistant seizures, in patients 2 years of age and older. The Japanese Ministry of Health, Labour & Welfare (MHLW) has also granted Orphan Drug Designation to FINTEPLA for the treatment of seizures associated with Dravet syndrome, which Zogenix is developing in Japan.