South Korea’s SK Biopharmaceuticals announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved Solriamfetol licensed out for U.S. sale to Jazz Pharmaceuticals, a global leader in sleep disorder disease.

It is the first approved novel drug in the pipeline of the company, and the first FDA-approved central nervous system drug developed by a Korean company.

SK Biopharmaceuticals discovered the compound and signed a license deal with Aerial Biopharma in 2011 after a phase I study was completed. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize the compound from Aerial Biopharma. Jazz Pharmaceuticals filed a New Drug Application (NDA) for Solriamfetol with the FDA in Dec. 2017.

The FDA approved Solriamfetol for the treatment of patients with excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy. Jazz Pharmaceuticals will market the drug the brand name of Sunosi in the United States.

Jazz Pharmaceuticals has global development, manufacturing, and commercialization rights to the drug, while SK Biopharmaceuticals maintains rights to 12 major Asian countries including Korea, Japan and China.

By Kim Byung-ho and Minu Kim

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