SK Biopharmaceuticals Seeks FDA Approval for 'Xcopri' in Generalized Seizures

Based on Phase 3 trial results
Significant reduction in seizure frequency

SK Biopharmaceuticals has begun the process of expanding the use of its epilepsy drug Xcopri (generic name: cenobamate) from focal-onset seizures to generalized-onset seizures. If approved, the drug will be available to treat a much larger patient population, which is expected to boost U.S. sales.

Image of SK Biopharmaceuticals' new epilepsy drug cenobamate. SK Biopharmaceuticals

On November 4, SK Biopharmaceuticals said it had submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) to add an indication for primary generalized tonic-clonic (PGTC) seizures in patients aged 12 and older. PGTC seizures cause patients to lose consciousness, stiffen all over, and then convulse. Xcopri has so far been used in the United States only to treat focal-onset seizures in adults.

The application was based on results from a global Phase 3 clinical trial announced in September last year. The trial enrolled 169 patients aged 12 and older with PGTC seizures at 122 sites across 12 countries, including the United States, South Korea, and countries in Europe. The median seizure frequency decreased by 71.9% from baseline in the cenobamate group and by 39.6% in the placebo group, a statistically significant difference between the two groups. Most adverse events were mild to moderate, and no new safety concerns emerged.

Since launching Xcopri in the United States in 2020, SK Biopharmaceuticals has managed the drug's lifecycle along three tracks: expanding the age range of patients eligible for treatment, adding new indications, and diversifying its formulations. In October, it submitted an sNDA to expand the focal-onset seizure indication for adults to include children. Earlier, in March, it also submitted a new drug application (NDA) for an oral suspension for patients who have difficulty swallowing pills. If all three applications are approved, healthcare professionals will be able to prescribe either tablets or suspension, depending on the patient's needs, to children with focal-onset seizures and patients with PGTC seizures.

Lee Dong-hoon, CEO of SK Biopharmaceuticals, said, "This application to add the PGTC indication is an important turning point that will not only broaden the patient population treatable with cenobamate but also expand the product's growth trajectory over the long term. Through a lifecycle management strategy spanning indications, age groups, and formulations, we will provide treatment options to more patients and strengthen our global competitiveness."

This content was produced with the assistance of AI translation services.