FDA Grants Priority Review to Relutrigine for Rare Epileptic Encephalopathies
The FDA has granted Priority Review to relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies, with a PDUFA target date of September 2026. Phase 2/3 trial data showed a 53% placebo-adjusted reduction in motor seizures and 66.2% increase in seizure-free days. If approved, it would be the first targeted therapy for these rare, fatal childhood conditions.