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SK Biopharmaceuticals has filed two supplemental NDAs with the FDA to expand Xcopri's (cenobamate) use — one for primary generalized tonic-clonic (PGTC) seizures in patients 12 and older, and another for focal-onset seizures in pediatric patients. Phase 3 data showed Xcopri nearly doubled placebo's seizure reduction. If approved, the drug could reach a significantly broader patient population.
SK Biopharmaceuticals is making a significant push to expand Xcopri's (cenobamate) reach. The company has submitted two supplemental New Drug Applications (sNDAs) to the FDA: one seeking approval for primary generalized tonic-clonic (PGTC) seizures in patients aged 12 and older, and a separate one to extend its existing focal-onset seizure indication to pediatric patients. Currently, Xcopri is only approved in the US for focal-onset seizures in adults.
The PGTC application is backed by a global Phase 3 trial enrolling 169 participants across 12 countries. The results were compelling — patients on Xcopri saw nearly double the seizure reduction compared to placebo, with no new safety concerns identified.
By the Numbers:
Why it matters: If both applications are approved, Xcopri could become a treatment option for a much wider epilepsy population — including adolescents and children — addressing a significant unmet need in seizure management.
