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Japan Again Postpones Approval Of Shionogi COVID Antiviral

Decision To Await Phase III Data

 
• By Lisa Takagi and Ian Haydock

Xocova’s emergency approval stymied by uncertainties over efficacy and other characteristics that could effectively limit its use, prompting decision to await Phase III data later this year.

MHLW's Discussion gathered nation-wide attention in Japan
Two-hour long discussion by MHLW gathered nation-wide attention • Source: Lisa Takagi

Advisory review committees of Japan’s Ministry of Health, Labour and Welfare (MHLW) have decided for the second time in the past month not to grant an emergency approval to Shionogi & Co. Ltd.’s oral COVID-19 drug Xocova (ensitrelvir; S-217622), casting further questions around the 3CL protease inhibitor's path to market.

Local interest in the once-daily drug has been high and also heightened by a recent spike in confirmed coronavirus cases in Japan to record levels, driven by the new BA.5 subvariant

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