On the 5th, the Ministry of Health, Labor and Welfare announced that Shionogi & Co., Ltd.'s drug for the treatment of the new coronavirus was subject to the "emergency approval" system, which rapidly approves drugs developed on an emergency basis only during infectious disease epidemics. Officially approved for use in normal procedures.
The drug that has been approved for use is Zocoba, a drug developed by Shionogi & Co., Ltd. to treat the new coronavirus.
The unique feature of this drug is that it can be taken even in patients with low risk of developing severe symptoms, even at the stage of mild symptoms.
"Zocova" was approved in November 2019, using the "emergency approval" system for the first time, which allows urgently developed drugs to be approved quickly if their efficacy can be estimated, but only in times of infectious disease outbreaks. and was approved for use.
The Ministry of Health, Labor and Welfare has requested that additional data demonstrating the efficacy of Zocoba be submitted within one year of the emergency approval and that Shionogi be able to apply for approval through normal procedures. I submitted an application to the Ministry of Health, Labor and Welfare in June last year with all the documents related to my gender and other information.
Then, on the night of the 4th, an expert meeting of the Ministry of Health, Labor and Welfare approved the use of the drug, stating that its efficacy had been confirmed and there were no serious safety concerns, and the Ministry of Health, Labor and Welfare officially approved it on the 5th.