SGIOF - Shionogi files for approval of COVID-19 oral drug in Japan

Shionogi (OTCPK:SGIOF) (OTCPK:SGIOY) filed for manufacturing and sales approval of its oral COVID-19 drug S-217622, in Japan. The company said it completed the analysis of primary endpoints in the phase 2b part of a phase 2/3 trial of S-217622, following which it requested review under the conditional early approval system in Japan. The study, which involved 428 people, was conducted mainly in infected patients after the Omicron variant wave of the epidemic to evaluate the effect of the drug when orally administered once daily for 5 days. At both doses, the drug arms showed a significant difference on day 4 (after the 3rd dose), against the placebo group. The study met a main goal of rapid reduction in viral titer. However, the drug did not meet the other main goal, as it could not show a significant difference in change in measure of 12 COVID-19 symptoms. The company said no new adverse events of

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Shionogi files for approval of COVID-19 oral drug in Japan