S-217622, a therapeutic drug for COVID-19, is filed with PMDA in Japan.-Shionogi
Shionogi & Co., Ltd. announced that Shionogi has completed the analysis of primary endpoints in the Phase II part of a Phase II/III clinical trial of S-217622, an orally administered antiviral drug for COVID-19, and has filed for manufacture and sales approval, requesting review under the conditional approval system in Japan.
The Phase IIb part of the Phase II/III clinical trial is a randomized, placebo-controlled, double-blind study in 428 SARS-CoV-2 infected subjects with mild/moderate symptoms (419 in Japan and 9 in South Korea). This study was conducted mainly in infected patients after the Omicron variant wave of the epidemic, and its main purpose is to confirm the antiviral effect and clinical symptom improvement of S-217622 (2 dose groups) when orally administered once daily for 5 days.
Shionogi will promptly submit further analyses of the data from this study to the Pharmaceuticals and Medical Devices Agency (PMDA) so that it can provide this therapeutic drug in Japan as early as possible. In parallel, Shionogi will accelerate the III3 part of the study in patients with asymptomatic/only mild symptoms (target subject number: 300 to 600) and will submit those data sequentially to the PMDA, as they are obtained.
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