The Ministry of Food and Drug Safety announced today (18) that the advisory group for the verification of Corona 19 treatment recommended that Celltrion's antibody treatment'Rekironaju' be given a license for the product under the premise of conducting phase 3 clinical trials.
The advisory group evaluated that the time it took for'Rekironaju' to improve corona symptoms was reduced by 3.43 days, and that there is statistical significance.
This means that after administering this drug to a patient who has any of the seven symptoms of COVID-19, including a fever, the time it takes for symptoms to disappear or to be determined to be weakened by 3.43 days.
It took 5.34 days for patients receiving Rekirona and 8.77 days for patients receiving placebo, and patients who took this drug recovered quickly by about 3.43 days.
However, the advisory group evaluated that there was no statistical significance at the time the virus was converted to'negative'.
There was a difference in the time for the virus to transition to negative among patients who received this drug or placebo, but this is of no clinical significance.
They also concluded that none of the patients who took either Rekironaju or placebo died, so the effect on mortality could not be judged.
These contents need to be judged through phase 3 clinical trials that will be conducted on many patients.
Accordingly, the advisory group proposed to grant the product approval for Rekirona on the premise of phase 3 clinical trials.
They also pointed out that in phase 3 clinical trials, it should be significantly confirmed that this drug blocks the transition to severe in mild and moderately ill patients.
The Ministry of Food and Drug Safety is planning to receive advice from the'Central Pharmacy Review Committee', a legal advisory body of the Ministry of Food and Drug Safety, by reviewing the submitted materials such as some quality data based on this advisory meeting.