SK Biopharmaceuticals has submitted a supplemental New Drug Application to the FDA seeking approval of cenobamate (XCOPRI) for the treatment of primary generalized tonic-clonic seizures and an expansion of the existing focal-onset seizure indication to include pediatric patients.
The submission is supported by positive results from a global Phase 3 trial evaluating cenobamate in patients 12 years of age and older with PGTC seizures. The trial enrolled 169 patients across 122 sites in 12 countries, including the U.S., South Korea and countries in Europe. Patients treated with cenobamate experienced a median 71.9% reduction in PGTC seizure frequency from baseline compared with a 39.6% reduction among patients receiving placebo, a statistically significant difference (p=0.003). Most reported adverse events were mild to moderate, and the safety findings were consistent with the known safety profile of cenobamate, with no new safety signals observed.
If approved, the new indication would expand cenobamate's use beyond its current indication for focal-onset seizures in adults.
The company also submitted a separate sNDA in October seeking to expand the focal-onset seizure indication to pediatric patients, confirming cenobamate's safety in clinical trials in pediatric patients with FOS. In March, SK Biopharmaceuticals submitted an NDA for an oral suspension formulation of cenobamate for patients who have difficulty swallowing tablets, a formulation also used in the pediatric clinical trial program.
CEO Donghoon Lee said the submission builds on the foundation established with cenobamate in focal-onset seizures in adults by evaluating its potential in additional seizure types, age groups and formulations.
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