SK Biopharmaceuticals expands cenobamate indications, aims to treat generalized seizures

[Financial News] SK Biopharmaceuticals is moving to expand its global market by broadening the treatment scope of cenobamate, its epilepsy drug. Its strategy is to extend the indication from partial-onset seizures to generalized seizures, while broadening the patient population to include children and offering a liquid formulation that is easier to take.
SK Biopharmaceuticals said it submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) on the 3rd (local time), seeking approval to add an indication for treating primary generalized tonic-clonic seizures (PGTC) in patients aged 12 and older with cenobamate, marketed in the United States as Xcopri.
The application was based on results from a global Phase 3 clinical trial involving 169 patients at 122 sites across 12 countries, including the United States, South Korea and countries in Europe. In the trial, the median seizure frequency in the cenobamate group fell 71.9% from baseline. The rate of reduction in the placebo group was 39.6%, and a statistically significant improvement was confirmed in the cenobamate group.
In the safety assessment, most adverse events were mild to moderate. The findings were consistent with the previously established safety profile, and no new safety concerns were observed.
Cenobamate is currently sold in the United States for adults with partial-onset seizures. If the FDA approves the application, its treatment scope will expand from partial-onset seizures to PGTC. PGTC is a type of seizure in which abnormal electrical signals occur in both sides of the brain, causing a loss of consciousness and full-body convulsions.
SK Biopharmaceuticals is also pursuing an expansion of the prescribing age range to include pediatric patients. Last October, it submitted an application to the FDA to extend the existing indication for adults with partial-onset seizures to children. Last March, it also applied for approval of an oral suspension (liquid formulation) developed to make the medication easier to take for patients who have difficulty swallowing tablets.
SK Biopharmaceuticals plans to strengthen cenobamate’s long-term growth prospects by expanding its indications, prescribing age range and formulations at the same time. Rather than stopping at the launch of a single new drug, the strategy is to gradually broaden the patient population and ways of taking the medication to enhance the product’s market competitiveness.
SK Biopharmaceuticals President Donghoon Lee said, “This application to add the PGTC indication is an important turning point in broadening the patient population for cenobamate and expanding the product’s growth trajectory over the long term.”

[email protected] Jung Sang-hee Reporter