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  • Xocova tablets 125mg approved in Japan for the tre...

Xocova tablets 125mg approved in Japan for the treatment of SARS-CoV-2 infection, under the Emergency Regulatory Approval System

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Published:25th Nov 2022

Shionogi & Co., Ltd. announced that Xocova (Generic name: ensitrelvir fumaric acid, Code No.: S-217622), a novel anti-SARS-CoV-2 drug for COVID-19 obtained emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the indication of SARS-CoV-2 infection

This approval was granted under the emergency regulatory approval system provided for in Article 14-2-2 of the Pharmaceuticals and Medical Devices Act.

In addition, a contract with the MHLW for the Japanese government to purchase 1 million courses of Xocova is now effective in accordance with the basic agreement for domestic supply of Xocova signed by Shionogi and the MHLW in March 2022

Xocova is an oral antiviral agent administered once daily for five days that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease. Shionogi filed for manufacturing and sales approval in Japan on February 25, 2022 based on the results obtained through the Phase IIb part of a Phase II/III clinical trial requesting review under the “conditional approval system”. On May 27, Shionogi refiled the application requesting review under the "emergency regulatory approval system" newly established after revision of the Pharmaceutical and Medical Device Act. Review by the Pharmaceuticals and Medical Devices Agency (PMDA) has been proceeding, and the emergency approval of Xocova was deliberated in the Pharmaceutical Affairs and Food Sanitation Council meeting including the newly submitted topline results of the Phase III part demonstrating achievement of the primary endpoint . Xocova is the first drug approved under the new emergency approval system.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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