[메디칼업저버 손형민 기자] An innovative new drug for epilepsy developed by SK Biopharmaceuticals (CEO Lee Dong-hoon), ‘Cenobamate’ (local product name: Xcofree) has been approved for sale in Canada.
SK Biopharmaceuticals announced on the 14th that Health Canada has issued a Notice of Compliance for cenobamad and approved its application for marketing approval in Canada.
Paladin Labs, a local pharmaceutical company, handles the commercialization of cenobamad in Canada.
For the first time in Korea, SK Biopharmaceuticals independently carried out the entire process from the discovery of cenobamamat new drug candidates to clinical development and application for marketing approval (NDA), and received approval from the United States Food and Drug Administration (FDA) in 2019.
Cenobamate is expected to gain approval in Canada four years after approval by the US Food and Drug Administration (FDA), accelerating its entry into the North American market, which accounts for more than half of the global epilepsy market.
