SK Biopharmaceuticals Submits sNDA to the US FDA for Cenobamate in Primary Generalized Tonic-Clonic Seizures

Shots: SK Biopharmaceuticals has submitted an sNDA to the US FDA seeking approval of cenobamate (Xcopri) for primary generalized tonic-clonic (PGTC) seizures & expansion of the existing focal-onset seizure indication to pediatric pts The PGTC filing is supported by a global P-III trial (NCT03678753; n=169 across 122 sites in 12 countries) in pts ≥12yrs., which showed a median 71.9% reduction in PGTC seizure frequency vs 39.6% with PBO (p=0.003), with safety consistent with the known profile A separate sNDA to expand focal-onset seizure use to pediatric pts was filed in Oct 2026, alongside a Mar 2026 NDA for an oral suspension formulation of cenobamate Ref: SK Life Science  |   Image: SK Biopharmaceuticals  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post SK Biopharmaceuticals Submits sNDA to the US FDA for Cenobamate in Primary Generalized Tonic-Clonic Seizures appeared first on PharmaShots.