SK Biopharm’s Epilepsy Drug ‘Xcopri,’ with ₩400 Billion ($290 Million) Annual U.S. Sales, Wins Korean Approval
SK Biopharm’s epilepsy medication Xcopri (generic name: cenobamate), which generates over ₩400 billion (approximately $290 million) in annual U.S. sales, has been approved as South Korea’s 41st domestically developed new drug.
The Ministry of Food and Drug Safety (MFDS) announced on November 3 that it has approved Xcopri Tab. (cenobamate) as an adjunctive therapy for adult patients with partial-onset seizures, with or without secondary generalization. The drug is expected to offer a new treatment option for patients whose seizures are not adequately controlled by existing antiepileptic medications.
Epilepsy is a neurological disorder characterized by recurrent seizures caused by abnormal electrical activity in the brain. About 30% of epilepsy patients are considered drug-resistant, meaning their symptoms cannot be controlled with current medications. According to data from the Health Insurance Review and Assessment Service, South Korea had approximately 152,000 epilepsy patients as of 2022.
With this approval, Xcopri has become Korea’s 41st domestically developed new drug. It is also the first product to be reviewed under the MFDS’s newly established “Guidelines for New Drug Approval and Review Procedures,” designed to expedite market authorization. The agency formed a 21-member task force dedicated to Xcopri, offering eight pre- and post-submission meetings with the company and prioritizing reviews of clinical (GCP) and manufacturing quality (GMP) data to accelerate the process.
The rapid approval was driven by strong patient demand. Xcopri has demonstrated superior efficacy and safety compared with other treatments, gaining global traction. It works by blocking sodium channels that transmit excitatory signals, thereby suppressing overactivation of neurons and reducing seizures. The drug is particularly effective in achieving seizure freedom and reducing seizure frequency in patients with treatment-resistant epilepsy.
Globally, Xcopri generated ₩547.6 billion ($394 million) in sales last year, including approximately ₩430 billion ($310 million) from the U.S. market alone. Its third-quarter sales surpassed $100 million, continuing to post record quarterly performance.
Despite its global success, Xcopri had not been available in Korea, prompting repeated calls for domestic approval from medical societies, patient groups, and even public petitions. In response, SK Biopharm signed an agreement with Dong-A ST in 2023, granting the company rights for regulatory approval, manufacturing, and sales across 30 countries. Dong-A ST submitted the Korean new drug application in February and secured approval roughly nine months later.
Dong-A ST said it plans to launch the product following reimbursement discussions, targeting a market release next year.
A company spokesperson stated, “Close collaboration with the MFDS was instrumental in the smooth approval of Xcopri. We will expedite the reimbursement process so that Korean epilepsy patients can gain timely access to this innovative therapy.”
