Regarding the oral medicine for the new coronavirus developed by Shionogi, the expert meeting of the Ministry of Health, Labor and Welfare agreed to allow its use, and then it was approved.
The feature is that it 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.
The new coronavirus oral drug "Zokoba" developed by Shionogi Pharmaceutical Co., Ltd. has been approved for use.
This drug 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 is characterized by the fact that it can be taken by patients with a low risk of becoming severe. .
After an application for approval for use was filed in February this year, it was deliberated in June and July under the `` emergency approval '' system for quickly approving developed drugs in an emergency. The decision was postponed and continued deliberations, and Shionogi subsequently submitted new results of the final stage clinical trials to the Ministry of Health, Labor and Welfare.
At an expert meeting of the Ministry of Health, Labor and Welfare held on the 22nd, it was recognized that it was effective in improving symptoms such as fever. Ministry of Health, Labor and Welfare approved.
It is the first oral drug developed by a domestic pharmaceutical company.
The Ministry of Health, Labor and Welfare has signed a contract to purchase 1 million doses from Shionogi after approval, and it is expected that supply to medical institutions will begin in the future.
Minister of Health, Labor and Welfare Kato held a press conference on the night of the 22nd, saying, "We hope that it will contribute to measures against the new coronavirus as one of the new treatment options, and domestic companies will manufacture and sell it, so from the perspective of stable supply. It is of great significance.As soon as the distribution system is established, we plan to start supplying it for use in medical settings at the beginning of December, and the medical institutions that can prescribe it will be published on the websites of prefectures.” said.
Prescription targets and expected effects
What kind of symptoms is it prescribed for?
What are the expected effects?
I will tell you in detail.
Shionogi & Co., Ltd. has been aiming for approval of "Zokoba" as the first oral drug that can be used even in people with a low risk of severe disease in the mild stage.
When the new coronavirus is infected, it invades the cell and copies the RNA of the virus itself to increase, but the new drug suppresses the proliferation of the virus by disabling the enzymes that work in the preparation stage for copying. .
The mechanism of action of the drug is the same as the oral drug "Pakilovid Pack" developed by Pfizer, a major American pharmaceutical company.
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.
According to this, in three countries such as Japan, from February to July this year, there were 1821 mild to moderate corona patients aged 12 to 60, including those who were not at risk of becoming seriously ill and those who were vaccinated. In a clinical trial targeting , if the drug was started within 3 days after the onset of symptoms, all five symptoms characteristic of the Omicron strain, namely coughing, sore throat, runny nose/stuffy nose, malaise, and fever/feeling of heat, disappeared around 7 days. It is said that the period during which symptoms were present was shortened by about 24 hours.
Dosing was done once a day for 5 days, but on the 4th day, the amount of virus was reduced to about 1/30 compared to those who received the placebo, and there were no serious side effects. and
Furthermore, experiments have shown that it is highly effective against mutated viruses including the Omicron strain BA.5, which is currently the mainstream.
On the other hand, since animal studies have shown effects on the fetus, it cannot be taken by women who are pregnant or who may become pregnant, and in some cases, it cannot be taken by those taking drugs to treat chronic illnesses. It seems.
The Ministry of Health, Labor and Welfare has signed a contract with Shionogi & Co. to purchase 1 million doses on the premise that pharmaceutical approval will be obtained, and the government will distribute it to medical institutions and the patient will not bear the cost for the time being.
In the past deliberations, approval was given twice
Regarding the new coronavirus oral drug 'Zokoba', Shionogi & Co. applied for approval to the Ministry of Health, Labor and Welfare in February, and was reviewed twice at an expert meeting. The judgment was shelved, and this time it was the third deliberation.
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 an "emergency" such as an epidemic of an infectious disease, on the condition that "there are no alternatives", " 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.
Expert "The drug that has been desired in the medical field"
Tsuneo Morishima, a visiting professor at Aichi Medical University who is familiar with the treatment of the new coronavirus, said, ``If you are infected with the new corona, you will be mild or your symptoms will be severe. While we don't know how long the disease will last, there has been a desire in the medical field for a drug that can be administered to people who are not at risk of becoming seriously ill."
He added, "It's true that the Omicron strain has become mainstream and the fatality rate has declined, but the percentage of people who die from chronic illness worsening is considerably higher than that of influenza, and there are cases where infected children become severe and die. Japan Compared to Europe and the United States, there are fewer people who have been infected and there are still few people who are immune to corona, so there is a high possibility that the wave of infection will continue, so it is unlikely that we will prepare therapeutic drugs and vaccines. It continues to be important," he said.