Japan's health ministry is to convene a meeting of experts on Tuesday to discuss whether to approve an oral coronavirus drug developed by Japanese pharmaceutical company Shionogi. If approved, it would be the first domestically developed oral drug for patients with mild COVID-19 symptoms.
The move comes after a ministry council decided in July to continue deliberating Shionogi's application for emergency authorization of the drug, Xocova, citing a lack of data. The company filed the application in February.
During Tuesday's meeting, experts will look into new clinical data Shionogi has submitted to prove Xocova's efficacy. The experts will also assess its safety.
Two other oral medications for mild COVID-19, both developed by foreign pharmaceutical firms, have been authorized for use in Japan. They are intended for use in patients at high risk of developing severe symptoms. Shionogi's Xocova is also available to low-risk patients.
The move comes after a ministry council decided in July to continue deliberating Shionogi's application for emergency authorization of the drug, Xocova, citing a lack of data. The company filed the application in February.
During Tuesday's meeting, experts will look into new clinical data Shionogi has submitted to prove Xocova's efficacy. The experts will also assess its safety.
Two other oral medications for mild COVID-19, both developed by foreign pharmaceutical firms, have been authorized for use in Japan. They are intended for use in patients at high risk of developing severe symptoms. Shionogi's Xocova is also available to low-risk patients.
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Summary
Japanese health ministry to convene experts meeting on Tuesday for approval of Shionogi's oral coronavirus drug, Xocova, making it the first domestic oral drug for mild COVID-19 cases. The decision follows a July council ruling that delayed emergency authorization due to lack of data, with the
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ID: ff5f4894-821b-402b-811e-af1fbb700358
Category ID: nhk
URL: https://www3.nhk.or.jp/nhkworld/en/news/20221122_04/
Date: Nov. 22, 2022
Created: 2022/11/22 07:18
Updated: 2025/12/09 11:19
Last Read: 2022/11/22 07:27