On the 10th, the Ministry of Health, Labor and Welfare will discuss the new coronavirus drug developed by Pfizer, a major American pharmaceutical company, for approval.
If there is a drug that is effective shortly after infection, it has been developed all over the world to reduce the number of seriously ill and fatal cases and the burden on medical care.
First approval is Merck's "Lagebrio"
The first drug of this type approved on December 24, 2021,
was "Lagebrio" = the generic name molnupiravir, developed by the American pharmaceutical giant Merck.
After the virus invades the cell, it prevents the growth by copying the "RNA" that is the blueprint and suppressing the action of the enzyme required for the growth.
According to the package insert of the drug, the target of administration is
▽ elderly people and those who are at risk of becoming severe such as obesity and diabetes
among mild to moderate patients over 18 years old
▽ within 5 days from the onset .
It is supposed to be taken twice a day for 5 days.
In addition, pregnant women and women who may be pregnant should not take this medicine because it may affect the foetation.
It is said to be effective in reducing the risk of hospitalization and death of patients at risk of aggravation by about 30%, and the rate of adverse events after taking the drug is the group who took the drug and the group who took the fake drug. It is said that it did not change.
The company has announced that in-laboratory analysis has "showed activity" against the Omicron strain.
The drug was
first approved in the United Kingdom in November 2021 and was approved for
emergency use in the United States on December 23, while
France initially expected it in clinical trials. I canceled my order because it wasn't as effective.
The Ministry of Health, Labor and Welfare has agreed to receive a supply of 1.6 million people, and a total of about 340,000 people is scheduled to be delivered by February 10, but stable supply is an issue.
Pfizer's medicine
Following "Lagebrio", an application for approval was submitted for a drug developed by the American pharmaceutical giant "Pfizer".
It is a combination of the antiviral drug "Nirmatrelvir" developed for the new coronavirus and "Ritonavir", which is an existing drug used for the treatment of AIDS and has the role of enhancing the effect of the antiviral drug. It is sold under the product name.
In Japan, the product name is "Pakirovid Pack", which is a type of drug that suppresses the growth of viruses that have invaded cells.
It has a different mechanism of action from Merck's "Lagebrio" and suppresses its growth by causing the virus to copy its own RNA and disable the enzymes that work in the preparatory stage of multiplying.
According to the final analysis of the clinical trial published by the company in December 2021, patients at risk of
aggravation have an 89% risk of hospitalization or death if they start administration within 3 days of onset. It
decreased, and
even if administration was started within 5 days of the onset, it was said to have decreased by 88%.
Regarding side effects, the rate of adverse events after taking the drug was the same between those who took the drug and those who took the fake drug, and most of them were mild.
In addition, laboratory analysis suggests that it may maintain strong antiviral activity against Omicron strains.
In the United States, the FDA = Food and Drug Administration issued an "emergency use authorization" on December 22, 2021, and
the target of administration is
▽ mild to moderately ill patients aged 12 years or older,
▽ high risk of aggravation. Being
a person,
▽ As soon as infection is confirmed, within 5 days if symptoms appear
▽ It is supposed to be taken twice a day for 5 days.
The government has announced that it has agreed to purchase 2 million people during the year, and expects to supply 40,000 people by the middle of this month as soon as it is approved.
Shionogi is also developing
At a Japanese pharmaceutical company, Shionogi Pharmaceutical Co., Ltd. in Osaka is developing a medicine for mildly ill patients.
The mechanism of action is similar to Pfizer's oral medicine, and it is said that the virus suppresses the growth of the virus by making the enzyme that works in the preparatory stage where the virus copies its own RNA and increases.
According to the company,
69 patients aged 12 to 60 years with mild, moderate, and asymptomatic
infections with the new corona are infectious
after receiving the
drug once or
three times a day.
The percentage of people with the virus decreased by
80% when the dose of the drug was high
and by 63% when the dose was low.
No one needed to be hospitalized, and the side effects were mild.
The company held a press conference in Tokyo on February 7, saying that the analysis results of 400 patients are expected to be gathered in the near future. He also expressed his intention to apply for approval to the government in the middle of the month.
If the approval is applied, it will be the first drug for the new corona of a domestic pharmaceutical company.
On the other hand, the company plans to complete production for 1 million people by the end of March 2022, and to produce more than 10 million people annually after April.
Expert "The emergence of new drugs is very significant"
Regarding the drug developed by Pfizer, Tsuneo Morishima, a visiting professor at Aichi Medical University who is familiar with the treatment of the new coronavirus, said, "A new drug will appear while the supply of the previously approved drug, Lagebrio, is limited. It is very significant. Also, the effect has been confirmed in vitro against the Omicron strain, and even when considering the mechanism of action, the effect does not decrease unlike vaccines and some antibody drugs, and it is effective. I think it is. "
On top of that, "In order for these medicines to be widely used, it is most important to have a system for testing, diagnosing, and prescribing as soon as possible at clinics, etc., but with the rapid spread of infection, many people are getting diagnosed. No. It is necessary to further expand the current inspection system. "
In addition, Pfizer's medicine is supposed to be taken by combining two kinds of medicines, but among them, "Ritnavir", which has the effect of enhancing the effect of antiviral drugs, said Visiting Professor Morishima, "In the blood of the medicine. There is a mechanism to increase the concentration, so be careful if you have an underlying disease and are taking another drug. When you get a prescription, it is important to check it by showing your medicine notebook to the doctor. I pointed out.
On the other hand, a domestic pharmaceutical company is developing a drug developed by Shionogi. It may become like a flu that you can return to work in a few days. "
Regarding the fact that the company has revealed the possibility of applying for approval without waiting for the results of the final stage clinical trial, "Even in the development of a therapeutic drug for corona overseas, if the effect becomes clear in the middle of the clinical trial, it will be approved. Applying has been commonplace, but to reinforce the small number of cases, it will be necessary to investigate side effects and effects after the drug has been widely used. "