The expert group of the Ministry of Health, Labor and Welfare began deliberations on the new coronavirus drug developed by Shionogi Pharmaceutical on the 22nd.
It is expected that the approval or disapproval will be decided next month as it is necessary to carefully discuss the effectiveness.
From the 22nd, the expert group of the Ministry of Health, Labor and Welfare began deliberation on the new corona drug "Zocova" (generic name "encitrelbil fumaric acid") developed by Shionogi Pharmaceutical.
It is a medicine that can be taken at the mild stage and was applied for last month using the newly created emergency approval system.
At the deliberation, the committee members commented that they should have it as a treatment option in preparation for the 7th wave, but pointed out that "the improvement in symptoms is small and there is no urgency to approve it because there are already other treatments." It means that there was.
After that, it was decided to continue the deliberation, saying that it is necessary to carefully discuss the efficacy and safety such as side effects based on the clinical trial data.
Approval is expected to be decided next month, and if approved, it will be the first drug developed by a domestic pharmaceutical company.
According to the company, the drug was tested in comparison with the group taking the fake drug, resulting in a 90% reduction in the percentage of people who detected the virus.
In addition, although there was no clear difference in 12 symptoms such as fatigue and body aches, the respiratory symptoms improved and the side effects were mild.
The Ministry of Health, Labor and Welfare has basically agreed to purchase one million people from Shionogi after approval and continue to purchase a certain amount thereafter.
What is Shionogi's corona drug?
Shionogi's new coronavirus drug is the first drug developed by a domestic pharmaceutical company that can be used at the mild stage.
When infected, the new coronavirus invades the cell and copies the RNA of the virus itself to increase it, but new drugs suppress the growth of the virus by making the enzyme that works in the copy preparation stage non-functional. ..
In February, Shionogi applied to the Ministry of Health, Labor and Welfare for approval of this drug, using the same mechanism as the "Pakirovid Pack," a drug developed by Pfizer, a major American pharmaceutical company.
According to the results of a clinical trial presented at the International Conference on Infectious Diseases in April, the spread of infection with the Omicron strain caused a new type of mild to moderate disease between the ages of 12 and 70 from January to February. According to a survey of 428 corona patients, after receiving the drug once or three times a day, there are five symptoms: ▽ cough and ▽ sore throat ▽ runny nose / stuffy nose ▽ shortness of breath, ▽ fever. Symptoms are said to have improved compared to the group taking fake medications.
On the other hand, when comparing the 12 symptoms including diarrhea and nausea, which were the initial endpoints, there was no clear difference compared to the fake drug group.
Also, the percentage of people who detected the infectious virus was 90% lower than in the group taking the fake drug, and the time to become negative for the virus was shortened by one to two days. is.
The company said there were no serious safety-related adverse events, and the company is also conducting final-stage clinical trials in parallel.