Zogenix 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. 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.