Commencement of special approval procedure for "REM DECIBIRU" Expected effect on new corona 11:48 on May 2
The Ministry of Health, Labor and Welfare has approved the urgent use of "lemdecivir", which is expected to have a therapeutic effect on the new coronavirus, in the United States. I entered the procedure. We are aiming for approval in about one week at the earliest, and once approved, it will be the first new coronavirus treatment 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.
Against this backdrop, the US government approved emergency use on the 1st, and the Ministry of Health, Labor and Welfare has begun the procedure for "special approval" of lemdesibir.
Regarding the data of clinical trials submitted to the U.S. government as soon as an application from a pharmaceutical company is received, a cabinet meeting for a cabinet order revision will be carried out in order to apply "special approval" to lemdecivir on the afternoon of the 2nd. We are seeking the opinion of an expert.
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, lemdecivir is limited in distribution volume, so it may be supplied only to certain hospitals under the control of the Ministry of Health, Labor and Welfare for the time being.