Cenobamate Proven Effective for Patients in Korea, China, and Japan
Plans Underway for Regulatory Approval in Northeast Asia
SK Biopharmaceuticals announced that its anti-epileptic drug Cenobamate has demonstrated clinical efficacy for patients in Northeast Asia, paving the way for expanding regulatory submissions globally.
The company presented Phase 3 clinical trial results for Cenobamate in Northeast Asian patients via a poster session at the 2024 American Epilepsy Society (AES) meeting in Los Angeles. The trial involved adult epilepsy patients in Korea, China, and Japan who had failed to respond to previous antiepileptic treatments.
According to the study, Cenobamate significantly reduced seizure rates across all dosages (100 mg, 200 mg, and 400 mg) during six weeks of adjunctive therapy. Notably, patients receiving the 400 mg dose achieved a median seizure reduction rate of 100%, compared to 25.9% in the placebo group.
The percentage of patients achieving complete seizure freedom during the six-week period also significantly favored Cenobamate. Rates were 12.4% in the 100 mg group, 30.1% in the 200 mg group, and 52.4% in the 400 mg group, compared to only 2.6% in the placebo group.
Additionally, Cenobamate significantly reduced partial seizure frequency during the fifth and sixth weeks of treatment, demonstrating its efficacy across various subtypes of epilepsy.
Epilepsy is the third most common neurological disorder worldwide, following stroke and dementia, with approximately 5 million new cases diagnosed annually. Cenobamate was previously approved in the U.S. in 2020 and in Europe in 2021, where it has been actively prescribed to adult patients suffering from uncontrolled seizures. Recently, the drug surpassed 140,000 cumulative prescriptions globally.
Based on the positive results from this trial, SK Biopharmaceuticals plans to collaborate with its Asian partners to file regulatory submissions in individual countries across the region.
Lee Dong-hoon, CEO of SK Biopharmaceuticals, stated, “This study paves the way for introducing a new treatment paradigm for patients in Northeast Asia. We remain committed to developing innovative global therapeutics to improve patients’ quality of life.”