Expected to be effective for the new corona "REMDecivir" Approved in about one week or May 2: 18:29
Regarding "lemdecivir", which is expected to have a therapeutic effect on the new-type coronavirus, the Ministry of Health, Labor and Welfare entered into a procedure for early approval under a system called "special approval", and the necessary cabinet order was amended on the 2nd. We are aiming for approval within one week at the earliest, and if approved, it will be the first therapeutic drug for a new coronavirus in Japan.
"Lemdecivir" is being developed overseas as a therapeutic agent for Ebola hemorrhagic fever, and clinical trials are underway in Japan as it can be expected to be effective against the new coronavirus.
While observing trends overseas, Minister of Health, Labor and Welfare Kato indicated that he would aim for early approval by utilizing a system called "special approval" that can greatly simplify examinations in Japan.
Under these circumstances, the US government approved emergency use on the 1st, and the Ministry of Health, Labor and Welfare has begun the procedure for “special approval”.
At the Cabinet meeting held on the afternoon of the 2nd, the Cabinet Order necessary to apply the "Special Approval" to the lemdesibir was amended, and the Ministry of Health, Labor and Welfare will open a council to examine clinical trials submitted to the U.S. government. We will seek expert opinion on the data.
The Ministry of Health, Labor and Welfare is aiming for approval in about one week at the earliest, and if approved, it will be the first new coronavirus treatment in Japan.
On the other hand, because lemdecivir has a limited distribution volume, it may be supplied only to certain hospitals under the control of the Ministry of Health, Labor and Welfare for the time being.
Domestic therapeutic drug research
Regarding the new coronavirus, research on the therapeutic effects of drugs used for different diseases in various countries is underway.
In Japan, the Ministry of Health, Labor and Welfare is conducting research on multiple drugs in collaboration with the National Center for Global Health and Medicine in Tokyo and Fujita Medical University in Aichi Prefecture, and clinical trials by pharmaceutical companies are also underway.
Among them, the influenza drug “Abigan” developed by a Japanese pharmaceutical company has been administered to 2194 patients as part of the study at 1100 medical institutions in Japan as of the 26th of last month.
While the study team reported that the treated patients had improved symptoms, they also said it would be difficult to judge the efficacy based on the current data alone.
In addition, since it has been pointed out that side effects on the fetus have been pointed out in animal experiments, the Ministry of Health, Labor and Welfare needs to carefully consider administration to men and women who may have children, not to pregnant women. I am.
a therapeutic drug for inhalation-type asthma, is being administered to patients and data collected at multiple medical institutions in Japan.
It has been reported that it may reduce the rate of exacerbations compared to no drug, and more research is needed to confirm its efficacy.
In addition to this, research is being conducted on the drug "Fusan" for pancreatitis and "Kaletra" that suppresses the onset of AIDS. Research is being carried out at companies.