SEOUL, Nov. 22 (Korea Bizwire) — SK Biopharmaceuticals Co., a biopharmaceutical affiliate of South Korea’s SK Group, said Friday its anti-epileptic drug has won approval from the U.S. Food and Drug Administration (FDA).
SK Biopharmaceuticals said the FDA granted approval of XCOPRI, or cenobamate tablets, for the treatment of partial-onset seizures in adults.
This is the first time a South Korean pharmaceutical company has independently earned the FDA approval without partnering or licensing out. SK Biopharmaceuticals has been developing the anti-epileptic drug since 2001.
“This FDA approval is a major step toward our goal of becoming a fully integrated global pharmaceutical company that can discover, develop and deliver new treatment options for epilepsy and the central nervous system,” Cho Jeong-woo, CEO of SK Biopharmaceuticals, said in a release.
With results from clinical trials on 2,400 patients in the world, SK Biopharmaceuticals submitted a new drug application for cenobamate tablets to the FDA last year.
SK Biopharmaceuticals said studies showed XCOPRI significantly reducing partial-onset seizure frequency, with up to 20 percent of patients achieving zero seizures during the maintenance phase.
XCOPRI is expected to be available in the United States in the second quarter of 2020, following a scheduling review by the U.S. Drug Enforcement Administration (DEA), according to the company.
Its U.S. affiliate SK Life Science Inc. will lead marketing and sales of the drug, SK Biopharmaceuticals said.
Epilepsy is a common neurological disorder characterized by seizures. According to industry data, the global anti-epileptic drug market is expected to grow to US$6.9 billion in 2022, up 12 percent from last year.