South Korea’s drug regulators approved SK Biopharmaceuticals’ epilepsy treatment Xcopri for domestic use on Nov. 3, marking an unconventional milestone as the nation’s 41st locally developed medicine. The drug gained Korean clearance six years after receiving US Food and Drug Administration approval, reversing the pharmaceutical industry’s typical sequence.
Xcopri generated more than 500 billion won ($354 million) in annual sales across the US and European markets before entering its home country. The medication, known generically as cenobamate, has been prescribed to over 140,000 patients internationally since its 2019 US launch.
Korean drugmakers traditionally seek domestic regulatory approval before tackling overseas markets, where clinical trial costs can reach hundreds of billions of won. SK Biopharmaceuticals pursued global development first, absorbing higher upfront expenses while delaying revenue from Korea’s smaller market.
The Ministry of Food and Drug Safety expedited Xcopri’s review following pressure from medical groups and patient organizations. The treatment targets partial-onset seizures in adults, a condition affecting roughly 30% of epilepsy patients who fail to respond adequately to existing medications.
Dong-A ST will handle Korean distribution following reimbursement negotiations with health authorities. The domestic launch positions SK Biopharmaceuticals to leverage proven overseas efficacy data in pricing discussions, potentially securing favorable terms unavailable to untested products.
