Clinical trial for approval of "Abigan" is behind schedule New corona June 11 5:33
The clinical trial for the approval of the new coronavirus drug candidate "Abigan" by the pharmaceutical company was delayed from the initial schedule and is expected to continue from next month.
"Abigan" is a new influenza drug developed by a Japanese pharmaceutical company, and the new coronavirus is also expected to be used mainly for mildly ill patients. I was aiming for approval during the month.
The drug company planned to conduct a clinical trial for clinical approval = a clinical trial from March to the end of this month targeting 96 patients in Japan, but according to the company, the clinical trial will be delayed from the scheduled time and continue after next month. It became a prospect.
The reason for this is that the number of infected people has decreased and the number of people who are subject to clinical trials has decreased.
As for abigan, clinical studies are being conducted on 86 patients at Fujita Medical University in Aichi Prefecture, etc. I want to finish.
On the other hand, regarding safety, it has been pointed out that side effects on the fetus may have been pointed out in animal experiments, etc., but there are no other serious side effects reported to over 3000 people who have been administered in observational studies by doctors so far. is.
The Ministry of Health, Labor and Welfare intends to proceed with the approval procedure after confirming the effectiveness of the drug in clinical trials and research.
The current status of new corona drug
As for the new coronavirus drug, "lemdecivir", which has been developed by an American pharmaceutical company, has been approved under a "special approval" system, and it will be used only for severely ill patients.
In addition, research is underway in Japan to apply existing therapeutic agents used for other diseases such as "Abigan" to the treatment of new coronavirus.
"Clinical trials" for approval, "observation studies" in which the drug is administered and the patient's condition is observed, and "clinical studies" in which the efficacy and safety of unapproved drugs are examined are being conducted.
The drug for treating asthma, Orvesco, is expected to be effective in preventing severe disease when used in early patients. In addition to observational research, clinical research is underway at 90 people at the National Center for Global Health and Medicine.
"Fusan", a therapeutic drug for pancreatitis and the like, has the potential to prevent the growth of the virus, as well as prevent blood clots and prevent the disease from becoming serious.
A drug company has begun clinical trials, saying that Huoipan, a remedy for pancreatitis, may also suppress the invasion of the virus into the body.
Actemra, a therapeutic drug for rheumatoid arthritis, is expected to suppress immune runaway caused by the new coronavirus, and pharmaceutical companies are conducting clinical trials in Japan and overseas.
In addition, clinical research at Kitasato University is planned for "Ivermectin", a treatment for infectious diseases caused by parasites.
In addition, observational studies on "Kaletra", which suppresses the onset of AIDS, were conducted early in the domestic outbreak, but so far no sufficient effect has been confirmed.