SEOUL, SK Group said Monday that it has applied to win U.S. approval for sales of an epilepsy treatment drug developed by its biopharmaceutical affiliate.
SK submitted the New Drug Application for the novel candidate substance, dubbed Cenobamate, with the U.S. Food and Drug Administration (FDA). If approval is given, this will pave the way for the company to sell the product in the key North American market.
Cenobamate, developed by SK Biopharmaceuticals Co., is a medicinal product for patients with partial epilepsy, the company said. The drug may be more effective and safer than existing treatment methods.
SK Biopharmaceuticals hopes to sell the drug in the United States from the first half of 2020. The global market for anti-epileptic drugs is forecast to expand to US$6.9 billion by 2022.
The company said it has conducted clinical trials on a combined 2,400 patients in the United States, Europe and Asia, making it eligible for the rarely granted permission. The drug had more effectiveness in treating seizure symptoms among patients who did not respond to existing treatments.
SK Biopharmaceuticals said it is focused on the development of innovative new drugs for disorders of the central nervous system and even to fight cancer. Currently, the company is pursuing eight clinical projects.
Source: Yonhap News Agency