Cenobamate by SK biopharmaceuticals Receives Market Approval in Canada

SK biopharmaceuticals has received Canadian market approval for its newly developed cenobamate epilepsy drug sold under the local product name Xcopri.

On June 14, SK biopharmaceuticals announced that Health Canada had issued a Notice of Compliance for cenobamate, approving its application for market authorization within the country.

Local pharmaceutical company Paladin Labs will handle the commercialization of cenobamate in Canada.

SK biopharmaceuticals is the first company in South Korea to independently carry out the entire process from the discovery of the candidate material for cenobamate, to clinical development, and to application for sales authorization, receiving approval from the U.S. Food and Drug Administration (FDA) in 2019.

Four years after FDA approval, cenobamate has now been approved in Canada, further accelerating its approach to the North American epilepsy market, which accounts for over half of the global epilepsy market.