SK Biopharmaceuticals Files FDA Application for Expanded Cenobamate Use

SK Biopharmaceuticals has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for its epilepsy medication, cenobamate, sold under the brand name XCOPRI. The filing seeks to expand the drug's therapeutic use to include primary generalized tonic-clonic (PGTC) seizures and to extend the existing approval for focal-onset seizures to pediatric patients.

The submission is supported by a global Phase 3 clinical trial involving 169 patients across 12 countries. Data showed a 71.9% median reduction in PGTC seizure frequency in the treatment group compared to 39.6% in the placebo group, with results proving statistically significant. The company reported that the safety findings were consistent with established clinical data for the drug.

CEO Donghoon Lee stated that the application is part of a broader development program aimed at evaluating the medication across diverse age groups and seizure types. In addition to the recent filing, the company submitted an sNDA in October specifically targeting pediatric focal-onset seizures and a separate application in March for an oral suspension formulation designed for patients with swallowing difficulties.

Since its U.S. launch in 2020, cenobamate has served as a treatment for adults with focal-onset seizures. The company is now focused on clinical expansion as part of its strategy to address unmet needs in the epilepsy community.