Korean drug firm Dong-A ST filed for marketing authorization of epilepsy drug Cenobamate with South Korean regulators, seeking to bring the treatment to its home market after successful launches in major Western nations.
The drug, marketed as Xcopri in international markets, generated 438.7 billion won ($321 million) in sales last year for developer SK Biopharm Co., marking a 62% increase from 2023. The company projects revenue to reach 610 billion won this year.
Dong-A ST acquired rights from SK Biopharm in early 2024 to manufacture and distribute Cenobamate across 30 countries. The agreement includes responsibility for securing regulatory approvals and managing production.
The treatment has already received green lights from the US Food and Drug Administration in 2019, European regulators in 2021, and Health Canada in 2023. SK Biopharm continues clinical trials to expand its use for generalized seizures and extend dosing approval to children and adolescents.
Dong-A ST indicates it’s collaborating with health authorities to expedite both approval and reimbursement listing in South Korea, according to a company representative.
Epilepsy affects about 65 million people globally, according to the World Health Organization. The condition, characterized by recurrent seizures, can significantly impact quality of life and requires consistent medication to manage symptoms.
The global epilepsy therapeutics market reached $16.6 billion in 2023 and is expected to expand at a compound annual growth rate of 3.7% through 2030, according to Grand View Research.
