The domestic introduction of SK Biopharmaceuticals’ epilepsy drug ‘Cenobamate’ (marketed as ‘Xcopri’ in the U.S.) is underway. Cenobamate, first launched in the U.S., has rapidly expanded its market presence, with cumulative prescriptions surpassing 140,000 patients.
On the 20th, Dong-A ST announced that it had submitted a marketing authorization application for Cenobamate to the Ministry of Food and Drug Safety (MFDS). The product will be marketed under the name ‘Xcopri.’
In January of last year, Dong-A ST signed a licensing agreement with SK Biopharmaceuticals and received the technology transfer for the production of Cenobamate as a finished drug product (DP). As a result, Dong-A ST will be responsible for the approval, sales, and production of Cenobamate in 30 global markets, including South Korea, Southeast Asia, Russia, Australia, and New Zealand.
Cenobamate is a novel drug independently developed by SK Biopharmaceuticals. It works by blocking sodium channels in the brain, which transmit excitatory signals, thereby normalizing the balance between excitatory and inhibitory neuronal activity. Multinational clinical trials have demonstrated significant efficacy, with a 55% reduction in seizure frequency and a 28% complete seizure-free rate among patients treated with Cenobamate.
In a Phase 3 clinical trial involving patients from South Korea, China, and Japan, announced in December of last year, significant improvements in seizure frequency reduction and complete seizure-free rates were also confirmed. SK Biopharmaceuticals is currently conducting additional clinical trials to expand Cenobamate’s use for generalized seizures and pediatric/adolescent patients.
Epilepsy is a condition where excessive excitation or inhibition of brain neurons causes involuntary movements or convulsive seizures, sometimes leading to loss of consciousness. Approximately 30% of epilepsy patients struggle with symptoms that are not controlled by existing medications, and some patients experience reduced seizure frequency or severity but still fail to achieve complete remission.
In response, epilepsy patients in South Korea have been calling for the introduction of Cenobamate, urging that a drug developed by a domestic company be made available to local patients. SK Biopharmaceuticals previously received U.S. Food and Drug Administration (FDA) approval for Cenobamate in 2019 and began selling it under the brand name ‘Xcopri’ in the U.S. in May 2020 through its U.S. subsidiary, SK Life Sciences. To date, the global cumulative number of patients prescribed Cenobamate has exceeded 140,000.
A Dong-A ST representative stated, “Dong-A ST is closely collaborating with health authorities to ensure the swift approval and reimbursement of Cenobamate, which has been recognized for its efficacy and safety in global markets. We are making every effort to ensure that patients can soon benefit from the innovative treatment that Cenobamate offers.”
