Sending time2021-01-18 21:02
comment
[앵커]
The drug company Celltrion’s No. 1 domestic treatment for Corona 19, Rekironaju, has been partially proven to have therapeutic effects.
However, the recovery period was clearly shortened, but the effect of removing the virus or treating severely ill patients was not clear.
Experts recommended approval based on phase 3 clinical trials.
This is a material reporter.
[기자]
Experts have concluded that Celltrion’s COVID-19 treatment, Rekironaju, has some effects in the treatment.
The clinical subjects were patients with at least one of the seven symptoms of COVID-19, such as fever and cough, but the recovery period for those who received the medication was 5.34 days, which was 3.43 days earlier than those who did not.
<김상봉 / 식품의약품안전처 바이오생약국장> “The reduction in the time for improvement of COVID-19 symptoms was statistically significant and was judged to be a clinically significant result.”
However, there was no difference in the time it takes for the virus to turn negative, but after administration, the virus concentration in the body was reduced.
The Ministry of Food and Drug Safety Advisory Group, which verified clinical trials, said that the virus measurement method was not standardized and that there was no clinical significance due to wide variation between results.
There were no specific side effects, but no clear conclusion was made as to whether it is effective in reducing severe transition and mortality.
Accordingly, it is the conclusion of the advisory group that it is desirable to approve the product of Rekirona on the premise of phase 3 clinical trials, but to administer it to mild patients within 7 days of onset of symptoms that do not require oxygen supply.
The government is planning to expedite the licensing process.
<정세균 / 국무총리> “If the screening process proceeds smoothly, it is expected that it will be able to serve as a reliable support force by being put into the corona 19 quarantine site from the beginning of next month.”
The Ministry of Food and Drug Safety plans to request Celltrion to submit some unsubmitted quality data this week.
This is Yonhap News TV’s material type. ([email protected])
Yonhap News TV article inquiries and reports: katok/line jebo23
Unauthorized reproduction-redistribution prohibited>
2021/01/18 21:02 sent