Japan's health ministry on Tuesday officially approved the oral coronavirus drug, Xocova, which was developed by the Japanese pharmaceutical company Shionogi.
The ministry's panel of experts confirmed the drug's efficacy and determined that there are no serious safety concerns at a meeting on Monday evening.
Xocova can be administered to patients, even those who have a low risk of becoming gravely ill, from the time that they exhibit mild symptoms.
The drug was granted emergency use authorization in November 2022. It was the first time that the ministry used a system that permits it to swiftly approve drugs.
The system allows for the speedy authorization of drugs that are quickly developed when infectious diseases are spreading, on the condition that they are expected to be effective.
The ministry had asked Shionogi to submit additional data regarding the drug's efficacy within a year, as part of its application for approval under the normal procedures.
Following the request, Shionogi submitted additional data to the ministry in June 2023.
The ministry's panel of experts confirmed the drug's efficacy and determined that there are no serious safety concerns at a meeting on Monday evening.
Xocova can be administered to patients, even those who have a low risk of becoming gravely ill, from the time that they exhibit mild symptoms.
The drug was granted emergency use authorization in November 2022. It was the first time that the ministry used a system that permits it to swiftly approve drugs.
The system allows for the speedy authorization of drugs that are quickly developed when infectious diseases are spreading, on the condition that they are expected to be effective.
The ministry had asked Shionogi to submit additional data regarding the drug's efficacy within a year, as part of its application for approval under the normal procedures.
Following the request, Shionogi submitted additional data to the ministry in June 2023.
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Summary
Japanese health ministry approves oral COVID-19 drug Xocova, developed by Shionogi, with no significant safety concerns. Granted emergency use authorization in November 2022. The approval system allows for swift authorization of effective drugs during infectious disease outbreaks. Shionogi
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ID: 0bbdb19c-067a-439d-8610-f5a0d7d9b3b2
Category ID: nhk
URL: https://www3.nhk.or.jp/nhkworld/en/news/20240305_19/
Date: March 5, 2024
Created: 2024/03/06 06:30
Updated: 2025/12/08 16:51
Last Read: 2024/03/06 11:25