Chugai Pharmaceutical Co., Ltd., which sells the drug for "antibody cocktail therapy" that can be used for mildly ill patients with the new coronavirus, held a briefing session on the 26th to support administration in outpatient clinics newly approved by the government. In order to do so, he showed the idea of securing the necessary supply.
"Antibody cocktail therapy" is a mixture of two types of antibodies that is administered by intravenous drip to suppress the action of the new coronavirus. It was approved in Japan last month and is targeted at medical institutions and accommodations for patients with mild to moderate illness. Administration at medical facilities has begun.
On the 26th, Chugai Pharmaceutical Co., Ltd., which sells this therapeutic drug in Japan, held a briefing session for the media in the form of a telephone conference.
In this, President Osamu Okuda said, "Delta stocks are widespread and demand for therapeutic drugs is increasing worldwide, but we would like to secure the necessary supply in response to the request from the Japanese government." He indicated that he would secure the necessary amount to support the newly accepted outpatient administration.
Professor Kazuhiro Tateda of Toho University, who is a member of the government subcommittee on measures against the new coronavirus, also attended the briefing session. Will be. "
Antibody cocktail therapy “Preventing the aggravation of mild cases”
"Antibody cocktail therapy" was approved this July.
By administering a mixture of two types of antibodies, "casilibimab" and "imdevimab," it has the effect of suppressing the action of the new coronavirus, and is used for the first time in mildly ill patients with the aim of preventing the aggravation of mildly ill people. Approved as a possible remedy.
It is necessary to administer within 7 days because there is no data to support the efficacy when administration is started after 8 days after onset, but in clinical trials conducted overseas, the risk of hospitalization and death is about 70%. The effect of reducing has been confirmed.
The US FDA (Food and Drug Administration) issued an urgent license in November last year for patients at high risk of worsening symptoms, saying that it would have a certain effect, and in October last year, the former President Trump of the United States made a new model. It was also used when I was hospitalized with a coronavirus infection.
Gradually expand the target The condition is "a system that allows sufficient observation"
The Ministry of Health, Labor and Welfare initially approved the use only for inpatients, saying that sufficient observation was necessary, but due to the rapid spread of infection, the number of patients who could not be hospitalized increased, so on the 13th of this month, a system that can be fully observed On the condition that it is in place, it is permitted to administer it at ▽ accommodation medical facilities and ▽ "hospitalization waiting station" set up as a temporary medical facility.
In addition, Prime Minister Suga said at a press conference on the 25th that administration would be permitted even in outpatient clinics.
(Prime Minister Suga)
"Neutralizing antibody drugs have already been administered to 10,000 people at 1,400 medical institutions, and there have been voices from the field saying that they are" extremely effective in preventing aggravation. " Although it has been considered only for inpatients, it can also be used outpatiently so that it can be used without being hospitalized. The required quantity is firmly secured. It will be used intensively for people with a certain condition to prevent its aggravation. "
Chugai Pharmaceutical discusses with the government to apply for "expansion of application"
In addition, President Okuda of Chugai Pharmaceutical Co., Ltd. announced at a press conference on the 26th that it is discussing with the government to apply for expansion of the scope of application, such as preventive administration to close contacts.
Corona remedy 4 approved in Japan
To date, four drugs have been approved for the treatment of the new corona in Japan.
1. Remdesivir
The earliest special approval in May 2020 for the treatment of the new coronavirus.
Originally developed as a treatment for Ebola hemorrhagic fever, it is administered by intravenous drip.
Initially, the target patients were limited to critically ill patients with ventilators and heart-lung machines = ECMO, but from January 2021, it will be administered to moderately ill patients with pneumonia. It is accepted.
2. Dexamethasone
Recommended as a therapeutic agent by the Ministry of Health, Labor and Welfare in July 2020.
Originally, dexamethasone, a steroid drug that has been used to treat severe pneumonia and rheumatism and has the effect of suppressing inflammation and allergies, was confirmed to be effective in reducing the death of severely ill patients in clinical trials conducted in the United Kingdom. I did.
In Japan, treatment with the antiviral drug remdesivir and dexamethasone is widely used, and it has become one of the factors that greatly reduced the case fatality rate due to the subsequent spread of infection compared to the first wave of infection in the spring of 2020. It is believed that it was.
3. Baricitinib
A drug such as rheumatoid arthritis that has the effect of suppressing inflammation and was approved in April 2021.
This drug is a tablet and is required to be taken in combination with remdesivir for moderately ill or higher hospitalized patients who require oxygen administration.
The combination of "baricitinib" and "remdesivir" in international clinical trials showed that patients recovered on average one day earlier than when "remdesivir" was given alone.
4. Antibody cocktail therapy
was approved in July 2021.
By mixing two types of antibodies, "casilibimab" and "imdevimab", and administering them by intravenous drip, it has the effect of suppressing the action of the new coronavirus, and was approved as a therapeutic drug that can be used for the first time in mildly ill patients.
The challenge is to secure a system
[Administration before
aggravation
]
The treatment is aimed at preventing the aggravation of mildly ill patients, and within 7 days because there is no data to support the efficacy when administration is started 8 days after the onset. Dosing is required.
However, with the spread of the infection, it has been pointed out that there are cases where the administration has already passed, such as the fact that many hospitalized patients are now moderately or severely ill.
For this reason, we have gradually expanded the scope of administration so that it can be administered to people with milder symptoms.
[Administration requires a system to prepare for side effects] In
clinical trials conducted overseas, 10 out of 4206 patients who received the drug had symptoms such as fever, dyspnea, decreased oxygen saturation, chills, and arrhythmia. It means that it was done.
A serious allergic reaction called anaphylaxis has also been reported.
In both cases, the condition has recovered, but the pharmaceutical company requires that the condition be observed for at least one hour after the administration is completed, and the Ministry of Health, Labor and Welfare requires that a system that allows sufficient health observation be secured for 24 hours. I am.
Experts also point out that it is necessary to carefully determine whether or not there are side effects peculiar to Japanese people.
[Securing the system] It
is necessary to secure the system including at night for "sufficient health observation for 24 hours".
As the medical system becomes tight, with the number of critically ill patients reaching a record high, the issue is how to secure the system.