Chugai has submitted an application to the Ministry of Health, Labor and Welfare for approval of a new coronavirus drug under development for which an emergency use authorization has been issued in the United States.
Two types of drugs called "casilibimab" and "imdebimab" have been submitted for approval.
We have adopted a treatment method called "antibody cocktail therapy" that produces neutralizing antibodies that suppress the action of the new coronavirus when administered at the same time.
According to Chugai, overseas clinical trials have confirmed the effect of reducing the risk of hospitalization and death by about 70%.
In November of last year, it obtained an emergency use authorization from the US FDA = Food and Drug Administration as a therapeutic drug for patients who have not been hospitalized, and on the 29th, it applied for approval to the Ministry of Health, Labor and Welfare.
It is said that it can be expected to have an effect on the mutated new coronavirus, and if approved, the Japanese government has agreed to secure the amount to be supplied domestically.
Chugai commented, "The epidemic has been prolonged, such as the spread of mutant virus infections, and new treatment options are needed. We will work closely with regulators to deliver them to patients as soon as possible." doing.