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SK Bio Gains FDA Approval for XCOPRI

Marks the first time a Korean company has independently brought a compound from discovery to U.S. FDA approval

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By: Kristin Brooks

Managing Editor, Contract Pharma

SK Biopharmaceuticals, Co., Ltd., and its U.S. subsidiary SK Life Science, Inc. received approval from the U.S. FDA for XCOPRI (cenobamate tablets) as a treatment for partial-onset seizures in adults.

The approval is based on results from two global, randomized, double-blind, placebo-controlled studies and a large, global, multi-center, open-label safety study that enrolled adults with uncontrolled partial-onset seizures, taking one to three concomitant anti-epileptic drug (AEDs). In the randomized studies, XCOPRI demonstrated significant reductions in seizure frequency compared to placebo at all doses studied.

The approval also marks the first time a Korean company has independently brought a compound from discovery to U.S. FDA approval.

“Today’s 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 in epilepsy and CNS,” said Jeong Woo Cho, Ph.D., president and chief executive officer of SK Biopharmaceuticals and SK life science. “We are grateful to the thousands of participants in our trials, clinical investigators, partners in the epilepsy community and our employees for their important contributions in bringing forward this treatment option for adults with partial-onset seizures.”

XCOPRI is expected to be available in the U.S. in 2Q20, following scheduling review by the DEA, which typically occurs within 90 days of FDA approval.
 

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