Two prominent Korean medical institutions have achieved a significant milestone in epilepsy treatment, securing therapeutic use approval for SK Biopharmaceuticals' anticonvulsant drug cenobamate. Chungbuk National University Hospital and SMG-SNU Boramae Hospital received their approvals from the Ministry of Food and Drug Safety (MFDS) for individualized patient use of cenobamate in treating epilepsy.
Breakthrough in Therapeutic Access
The approvals represent the first successful medical team applications for epilepsy treatment since SK Biopharmaceuticals received initial approval for partial-onset seizures in July 2022. This therapeutic use approval mechanism enables exceptional access to unlicensed medications for patients with life-threatening or severe conditions, with physicians applying directly to MFDS for specific patient cases.
Strategic Commercial Development
In a parallel development, Dong-A ST has submitted an application for domestic product licensing to the MFDS, following a comprehensive license-in agreement with SK Biopharmaceuticals signed in January 2023. The agreement grants Dong-A ST rights for licensing, sales, and finished drug product manufacturing across 30 countries, including Korea, East and South Asia, Russia, Australia, New Zealand, and Turkiye. The companies have projected a domestic market launch with reimbursement coverage by 2026.
Clinical Impact and Market Performance
Cenobamate, marketed as XCOPRI in the United States since May 2020, has demonstrated remarkable market penetration, reaching over 140,000 patients. Professor Shin Won-chul from Kyung Hee University Hospital's Department of Neurology and pharmaceutical director at the Korean Epilepsy Society emphasized the drug's superior efficacy compared to existing treatments.
"Cenobamate has already been successfully launched and is selling well in the U.S., and its efficacy is said to be superior to existing drugs, so I have high expectations," stated Professor Shin.
Addressing Unmet Medical Needs
The introduction of cenobamate addresses a critical gap in epilepsy treatment, where approximately 30-40% of patients experience inadequate control with current medications. The drug offers new hope for patients with drug-resistant and intractable epilepsy, though pricing considerations remain a significant factor in its accessibility.
Market Access Challenges
Professor Shin highlighted concerns regarding drug pricing in Korea, noting that patent expiration and pricing mechanisms based on existing treatments could impact market access. "It's good to save health insurance finances, but Korea shouldn't try to promote only domestic drugs while shutting doors to foreign products," he cautioned, emphasizing the need for balanced market access policies that ensure patient access to innovative treatments.
