Shionogi's COVID-19 drug Xocova receives European marketing authorization for preventive use

Shionogi’s COVID-19 treatment Xocova received marketing approval from the European Commission for preventive use. It is Europe’s first approval for preventive use and has already been approved in Japan and the United States.

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The story

The European Union’s regulatory authorities approved Shionogi’s oral COVID-19 drug Xocova for preventive use. This allows it to be used for prevention in Europe and indicates that it could become a new option for use alongside standard vaccines.

Shionogi received approval in Japan and the United States in 2026. The company aims to expand global sales through broader approval in Europe.

Clinical trial data showed that, among patients’ household members and others who took Xocova, the risk of developing COVID-19 by day 10 after dosing was 67% lower than in the placebo group.

At a glance

TimingThe European Commission granted approval for preventive use (the first preventive-use approval in Europe)

ApplicationApproval for preventive use, becoming Europe’s first preventive approval for an oral drug

Expected benefitsThe risk of developing the disease fell 67% within 10 days of dosing among household members and others

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