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.
Shares in Shionogi & Co posted their steepest fall in three months on Thursday after a health ministry panel again delayed emergency approval for the Japanese drugmaker's oral treatment against COVID-19.
The stock dropped 8.5% to 6,901 yen as of 10:22 JST, the most since April 13, leading decliners on the benchmark Nikkei index, which was down 0.4%.
Health experts on the panel voted on Wednesday to await more data from ongoing clinical trials and continue discussions on the drug, dealing another blow to Shionogi's global ambitions for the antiviral pill.
July 21, 2022
