Xcopri (generic name: cenobamate), an epilepsy drug developed by SK Biopharmaceutical, has completed its initial domestic shipment and is now available for prescription in South Korea. Korean patients who previously obtained the medication in the United States are expected to save up to $200 a month through national health insurance coverage.
According to industry sources on the 3rd, shipments of Xcopri tablets have been completed following preparations for domestic supply. The drug has been covered by national health insurance since the 1st of this month and can be prescribed at medical institutions that have completed their internal drug-registration procedures.
A Dong-A ST representative said, “Preparatory work was completed in advance, and shipments have been finalized. We understand that most major general hospitals have passed the review of their pharmacy and therapeutics committees.” However, the timing of availability may vary depending on each hospital’s adoption procedures.
Industry sources expect patients who previously received Xcopri prescriptions in the United States to save up to $200 per month in medication costs now that the drug is covered domestically. The start of local supply is also expected to reduce the inconvenience of having to obtain the medication overseas.
Xcopri is an oral treatment for adults whose seizures are not adequately controlled with existing anti-seizure medications. In South Korea, it is approved as an adjunctive therapy for partial-onset seizures, with or without secondary generalized seizures. It is taken in addition to a patient’s existing medication to help improve seizure control.
Epilepsy is a chronic neurological disorder characterized by recurrent seizures caused by abnormal electrical signals in the brain’s nerve cells. Medication is the primary treatment, but seizures are known to persist in approximately 30% of patients despite adequate treatment. Seizures can cause physical injuries, including falls and burns, and interfere with education and employment. As a result, achieving complete seizure freedom, not merely reducing seizure frequency, is considered an important treatment goal.
Xcopri has a dual mechanism of action: it suppresses excessive neuronal activity and enhances the effects of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter. It is taken once daily, with the dose gradually increased according to the patient’s condition.
The pivotal clinical trial supporting approval by the U.S. Food and Drug Administration (FDA), known as Study 017, demonstrated reductions in seizure frequency and complete seizure freedom. The study enrolled 437 adults with focal-onset seizures that were not adequately controlled by existing medications. Seizure frequency in the cenobamate 200 mg and 400 mg groups fell by approximately 55% from baseline.
Notably, during the 12-week maintenance period, 11% of patients in the 200 mg group and 21% in the 400 mg group experienced no seizures, compared with 1% in the placebo group. An Asian Phase 3 trial involving 519 patients from South Korea, China and Japan also found that complete seizure freedom during the six-week maintenance period was achieved by 30.1% and 52.4% of patients in the respective treatment groups, compared with 2.6% in the placebo group.
Although Xcopri was developed by a South Korean company, it was commercialized overseas first. It received approval in the United States in 2019 and Europe in 2021. In South Korea, it was approved on November 3 last year as the country’s 41st domestically developed new drug. National health insurance coverage followed approximately one year after its domestic approval.
Dong-A ST is responsible for domestic manufacturing and sales. In January 2024, the company acquired from SK Biopharmaceutical the rights to obtain regulatory approvals, sell the product and manufacture the finished drug in 30 countries, including South Korea. The approved domestic product is manufactured at Dong-A ST’s Songdo Campus.
