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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 rand...

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