Conditional recommendation of’prerequisites for conducting phase 3 clinical trials’
Prime Minister Jeong Sye-gyun, “Korea No. 1”
Expect to put in quarantine sites from early next month”
Celltrion’s Corona 19 treatment,’Rekironaju’, received a recommendation for product approval from the Ministry of Food and Drug Safety’s treatment verification advisory group.
The Ministry of Food and Drug Safety announced on the 18th that the COVID-19 treatment verification advisory group recommended that the celltrion antibody treatment Rekkironaju (ingredient name Regdanvimab code name CT-P59) be approved under the premise of conducting phase 3 clinical trials.
This is because the treatment showed statistical significance, such as reducing the time to improve the symptoms of Corona 19 by 3.43 days. However, there was no statistical significance at the time when the virus was converted to’negative’.
The advisory group measured the time it took until it was judged that all seven symptoms disappeared or weakened after administering this drug to a patient who showed at least one of the seven corona19 symptoms such as fever.
As a result, patients who received 40 mg of Rekirona per 1 kg of body weight recovered after 5.34 days, and patients who received placebo (a sham drug administered to control the effect of clinical drugs) were recovered after 8.77 days. It was confirmed that the patient who received the drug recovered quickly about 3.43 days.
The advisory group determined that the reduction in the time for improvement of Corona 19 symptoms with the administration of this drug was statistically significant and clinically significant.
However, the Ministry of Food and Drug Safety said, “It is difficult to say whether improvement of symptoms will lead to shortening of discharge time.”
Meanwhile, Prime Minister Jeong Sye-gyun said at the Central Disaster and Safety Countermeasure Headquarters meeting at the Seoul Government Complex on the same day, “If the remaining screening procedure proceeds smoothly, then quarantine from the beginning of next month. We expect to be put into the field and serve as a reassuring support force,” he said.
/ Reporter Myungho Kim [email protected]