Rekirona are expanded to 50 years of age or older

It was changed by reflecting the results of phase 3 clinical trials

The MFDS approved the official approval based on the results report of phase 3 clinical trials of Celltrion's COVID-19 antibody treatment Rekirona, which completed phase 3 global submitted by the company.

 

It has expanded the subject of administration.

 

However, mild patients were not included.

 

The MFDS announced on the 17th that it had carefully reviewed the results of a global phase 3 clinical trial of Rekirona (Regdanvimab), a domestic COVID-19 antibody treatment submitted by Celltrion on the 10th of last month, and approved the change to delete the permit conditions and expand the range of patients who can be administered.

 

As the efficacy and effect of Rekirona was allowed to be changed to "treatment of mild and all secondary adult patients at high risk of COVID-19", the number of patients who can be treated increased.

 

The previous high-risk patients were over 60 years old or with underlying diseases (one or more of cardiovascular disease, chronic respiratory disease, diabetes, and high blood pressure), which lowered the target's age to over 50 years old and added obese people (BMI index 30 or more), chronic kidney disease (including dialysis), chronic liver disease, bone marrow transplantation.

 

The administration method also shortened the administration time from intravenous administration for 90 minutes to 60 minutes.

 

The MFDS explained that the overall safety of Rekirona was good.

 

In phase 3 clinical trials, the incidence of abnormal cases of Rekirona was similar to that of the placebo group, and most of the symptoms were mild or moderate.

 

The most frequently reported abnormal cases included elevated liver enzyme levels and hyperglycermia, and significant abnormal cases were "injection-related reactions" (one patient), recovering within a few days.

 

It has been confirmed that the effectiveness of Rekirona significantly reduces the duration of severe exacerbation and clinical recovery due to COVID-19.

 

Among mild and secondary patients administered Rekirona, the rate of severe transmission from 446 high-risk patients decreased by 72% compared to placebo (434 patients), and the clinical recovery period was also shortened by 4.12 days compared to placebo (12.3 days).

 

The MFDS explained that it consulted experts on the 3rd and the Central Pharmaceutical Affairs Council on the 10th on whether the results of Rekirona's phase 3 clinical trial could therapeutically confirm the effectiveness of the drug in the patient group that Celltrion applied for change.

 

As a result, experts agreed that it is reasonable to delete the permit conditions and switch to formal permission, and that it is desirable to expand the scope of high-risk groups and apply them to high-risk mild and all secondary adult patients.

 

However, in the case of mild symptoms other than high risk, the frequency of severe morbidity was low, and there was insufficient confirmation of effectiveness, so it was not included in the scope of use.

 

In addition, it was suggested that it is reasonable not to include children over the age of 12 in the scope of use because they are not included in the clinical trial.

 

The MFDS reviewed the results of the review and advisory opinions and decided on the scope of the drug's use as "all secondary adult patients in mild to high-risk groups" identified in the clinical trial.