Japan Considers Early Approval for Shionogi COVID-19 Pill

Japanese Prime Minister Fumio Kishida said on Monday that the government is weighing on a conditional early approval for an anti-COVID-19 pill developed by Shionogi & Co.

Kishida told a parliamentary committee that the drug should be reviewed “promptly” once clinical trials confirm its safety and efficacy.

Japan’s Maniachi newspaper earlier reported that the government is considering a fast-track approval for the Shionogi drug to begin rolling out as early as this spring.

Should the approval push through, Shionogi CEO Isao Teshirogi said that the company can deliver enough doses for 1 million people by the end of March, with additional doses for 10 million more people next year.

The company said that an ongoing trial for their pill showed a “significant difference” in antiviral effect compared to a placebo and an improvement in symptoms. It plans to enter Phase III trials and expand to a global trial later this month.


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