The drug, a protease inhibitor known as ensitrelvir, met its primary endpoint in a trial conducted among predominantly vaccinated patients with mild to moderate cases of COVID-19, the company said in a statement.
Ensitrelvir met the trial's goal in reducing five key symptoms of the Omicron variant of COVID-19 within 72 hours of onset, the company said. Shionogi said it has shared top-line data from the Phase III study with Japanese regulators as part of deliberations on approval of the drug.
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