SK Biopharma Seeks Broader Cenobamate Approval
On Nov. 3 local time, SK Biopharmaceuticals submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking an expanded indication for primary generalized tonic-clonic seizures (PGTC) in patients aged 12 years and older. The filing was based on results fro
SK Biopharmaceuticals has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to seek broader approval for the drug cenobamate. The request aims to expand the drug's indication for primary generalized tonic-clonic seizures (PGTC) in patients aged 12 years and older. This filing, based on results from a global Phase 3 clinical trial involving 169 patients across 12 countries, demonstrated that cenobamate significantly reduced the frequency of PGTC seizures by 71.9% compared to a 39.6% reduction in the placebo group.
SK Biopharmaceuticals expects this expansion to enhance the drug's market competitiveness and provide a new treatment option for a wider range of epilepsy patients, including those with generalized seizures. The company is also working on lowering the eligible patient age group and improving the ease of administration, with a recent submission to expand the partial-onset seizure indication to pediatric patients.
Additionally, SK Biopharmaceuticals is diversifying formulations by pursuing approval for an oral suspension, which will allow medical professionals to choose between tablets and suspension based on individual patient needs.
Brief written by urgent.news from BusinessKorea's own syndicated text. Machine-written — may contain errors; check the original before relying on it.
