SK Biopharmaceutical said Thursday that the U.S. Food and Drug Administration has begun the inspection of the company’s new drug application (NDA) for Cenobamate, an epilepsy treatment candidate.
The company had submitted the NDA in November last year after confirming the efficacy and safety of the drug in a large-scale clinical trial participated by 1,900 patients. SK Biopharm presented the results of the trial at the annual meeting of the American Academy of Neurology (AAN) and the American Epilepsy Society (AES).
SK expects that the FDA will grant the final approval on the drug on Nov. 21 as the process takes approximately 10 months, following the Prescription Drug User Fee Amendment.
Cenobamate is the first epilepsy drug independently developed by a Korean company, beginning from candidate discovery to the FDA application, without making technology export. If SK Biopharma obtains FDA’s marketing approval, it plans to commercialize the product through SK Life Sciences, a U.S. subsidiary of the company.
“Over the past decade, we have been interacting with the clinicians and patients in the U.S. about the efficacy and safety of Cenobamate,” SK Biopharma CEO Cho Jeong-woo said. “Our goal is to become a global pharmaceutical company through the commercialization of Cenobamate.”