The Ministry of Health, Labor and Welfare has approved the use of the new oral drug "Zokoba" for the new coronavirus.
It is a therapeutic drug that can be taken from the mild stage even for patients with a low risk of becoming severe, and it is the first oral drug developed by a domestic pharmaceutical company.
what kind of medicine
What is the effect?
Summarized by QA method.
Q. What is "Zokoba"?
The new coronavirus oral drug "Zokoba" developed by Shionogi Pharmaceutical Co., Ltd. has been approved for use.
It is an oral drug for the new coronavirus that can be taken from the mild stage, and unlike previous drugs that were targeted at patients with a high risk of becoming severe, it can be taken by patients with a low risk of becoming severe.
So far, nine types of drugs, including oral drugs and intravenous drips, have been approved as therapeutic drugs for the new coronavirus, and some drugs can be used for patients with mild to moderate symptoms, but there are risks of aggravation such as diabetes, various respiratory diseases, and obesity. Limited to one person.
There were no trials in people at low risk of severe disease, and supplies were limited.
"Zokoba" is an oral drug that can be used widely like "Tamiflu" for influenza, and can be used by people over the age of 12 who have a low risk of becoming seriously ill.
At an expert meeting of the Ministry of Health, Labor and Welfare held on the 22nd, it was evaluated that it was 'presumed to be effective' because it was effective in improving symptoms such as fever, and it was approved to be used.
It is also the first oral drug developed by a domestic pharmaceutical company, and is expected to lead to a stable supply to medical institutions.
Q. What is the effect of the medicine?
Regarding "Zokoba", Shionogi & Co. announced in late September that it was confirmed that the period of symptoms such as fever was shortened and the effect of improving symptoms was confirmed in the final stage clinical trial.
From February to mid-July, 1821 patients with mild to moderate symptoms of corona, aged 12 to 60, including those who were not at risk of becoming seriously ill and those who had been vaccinated, were tested in three countries, including Japan. It was aimed at
In the group that started taking the drug within 3 days after the onset of symptoms, all 5 symptoms characteristic of Omicron strain, namely cough, sore throat, runny nose/stuffy nose, malaise, and fever/febrile sensation, all disappeared after about 7 days. It means that the period that was out has been shortened by about 24 hours.
Q. How does the drug work?
When the new coronavirus is infected, it invades the cell and copies the RNA of the virus itself and increases, but the new drug `` Zokoba '' stops the enzyme that works in the preparation stage for copying from functioning. reduce the
The mechanism by which the drug works is similar to the oral drug `` Pakilovid Pack '' developed by the American pharmaceutical giant Pfizer, which has already been approved as a drug for the new coronavirus.
Q. What are the side effects?
In the clinical trial, administration was performed once a day for 5 days, but on the 4th day, the amount of virus was reduced to about 1/30, and there were no serious side effects.
Furthermore, experiments have shown that it is highly effective against mutated viruses including the Omicron strain BA.5, which is currently the mainstream.
However, it should not be used by women who are pregnant or who may become pregnant, as animal studies have shown it to be harmful to the fetus.
In addition, if you are taking medicine for the treatment of chronic illness, there is a possibility that side effects may occur depending on the combination with other medicines, so we will appropriately call attention.
Q.When can I use it?
Regarding "Zokoba", the Ministry of Health, Labor and Welfare has signed a contract with Shionogi Pharmaceutical Co., Ltd. to purchase 1 million doses, and will start supplying it as soon as a distribution system is established so that it can be used in medical settings around the beginning of December. I'm here.
In addition, because pregnant women are prohibited from using it, and multiple medicines are prohibited from being used in combination, for the first two weeks or so, as a safety measure, it is recommended that American pharmaceuticals with similar mechanisms of action be used. We plan to limit the number of cases to medical institutions and pharmacies that have a track record of prescribing the oral medicine developed by Pfizer.
After that, no special requirements will be set, and after establishing a system that allows prescriptions at medical institutions selected by each prefecture and dispensing at pharmacies, medical institutions that can prescribe will be published on the websites of prefectures, etc. I'm assuming.
Q. Will the necessary measures change with the approval of Zokova?
It has been nearly three years since the spread of the new corona infection began, but "vaccines" and "therapeutic drugs" were mentioned from an early stage as key measures.
Vaccines are now widely used, but the important thing is that even if you get infected, you won't get sick.
If there is a drug that can be used at an early stage after infection, the number of people who become seriously ill can be reduced.
The addition of "drinking medicine", which is said to be relatively easy to use as a therapeutic drug, is important in order to live in a situation where corona cannot be eliminated.
On the other hand, even if both "vaccines" and "easy-to-use therapeutic drugs" become available, there may still be cases of infection and aggravation. Experts point out that infection control such as avoidance and vaccination are important.
Q. What are the experts who are familiar with the treatment of the new corona?
Tsuneo Morishima, a visiting professor at Aichi Medical University who is familiar with the treatment of the new corona, said, ``While it is unknown whether the symptoms will be mild or severe after being infected with the new corona, medicines that can be administered to people who are not at risk of becoming severe are medical. It has been desired on site," he said.
Regarding the effect of the drug, ``The clinical trial showed that it had the effect of speeding up the improvement of symptoms such as coughing and fever by one day, but the influenza drug is considered to have a sufficient effect at the same level, and the viral load is also reduced. If it is used in nursing homes and hospitals where there are many people at high risk of becoming seriously ill, it can prevent the worsening of symptoms and the spread of infection, leading to dysfunction in the workplace. As an issue for the future, he said,
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Since this drug is said to be more effective if taken within three days of the onset of symptoms, the national and local governments need to establish a system for earlier diagnosis and faster drug delivery." It is important that the drug is put in place as soon as possible, and it is necessary to continue to monitor whether there will be unexpected serious side effects when this drug becomes widely used, and whether the virus will develop resistance. In the future, it is also necessary to clearly show that data will be provided on how much the risk of aggravation and death can be reduced after all."
Q. What is the process to approval?
Regarding "Zokoba", after Shionogi & Co. applied for approval to the Ministry of Health, Labor and Welfare in February this year, it was reviewed twice at an expert meeting, but in both cases the decision on effectiveness was postponed. This was the 3rd hearing.
In the procedure for "pharmaceutical approval" that allows the use of therapeutic drugs and vaccines developed by pharmaceutical companies, it usually takes about one year from application to approval. It was pointed out as one of the factors behind the delay.
In response to this, in May this year, in order to quickly approve vaccines and therapeutic drugs developed in Japan and overseas on the condition that there are no alternatives in an "emergency" such as an epidemic of an infectious disease. A new “emergency approval” system has been established.
"Zokova" was also to be reviewed under the framework of "urgent approval", and the first deliberation was held at the expert meeting in June, but the decision was postponed due to the need to carefully discuss the effectiveness and other matters. was given.
At the second meeting, which was held a month later in July, the decision was postponed again, saying, "It is not possible to make a judgment that the effectiveness can be presumed," and continued deliberations.
Under these circumstances, in light of the “seventh wave” in which medical institutions were under pressure, the Japanese Association for Infectious Diseases and others in September made a proposal to the Ministry of Health, Labor and Welfare for early approval, saying that an oral drug that can be taken by patients with a low risk of becoming seriously ill is necessary. had submitted.
Q. Operation of the emergency approval system
Regarding this review, Associate Professor Shunsuke Ono of the University of Tokyo, who is familiar with the pharmaceutical affairs system, said, "Under the emergency approval system, the extent to which efficacy and safety should be demonstrated was not shared among the committee members and the reviewing authorities. I got the impression that the discussions were chaotic. He pointed out that the balance between "promptly conducting drug testing" and "confirming the efficacy and safety of drugs" has become a new challenge.
On that point he pointed out:
"The government will not make improvements such as making the system more transparent and reducing the burden, such as indicating the minimum level of effectiveness in clinical trials and the specific line to be approved. Isn't it going to be a system like a rice cake that I drew?"