Japan’s Health Ministry Delays Emergency Approval of Shionogi’s COVID-19 Treatment

Japan’s Health, Labor and Welfare Ministry panel postponed a decision to approve Shionogi’s oral COVID-19 antiviral drug Xocova.

The ministry cited a lack of evidence of the drug’s efficacy in clinical trials and said it will wait for the results of a phase 3 study expected in November. This is the second postponed decision for Xocova — the previous deferral was in June.

If approved, Xocova would be the third COVID-19 oral treatment approved in Japan. So far, Pfizer’s Paxlovid (nirmatrelvir, ritonavir) and Merck and Ridgeback Biotherapeutics’ Lagevrio (molnupiravir) are the oral drugs approved in Japan for COVID-19.