Conditional approval of the first domestic treatment… Some concerns in expectations
[뉴스리뷰]
[앵커]
The first domestic corona antibody treatment drug developed by Celltrion, Rekirona, has received a conditional approval decision.
It is also the third in the world.
However, the limited scope of use and the uncertainty due to the appearance of mutant viruses are challenges to be solved in the future.
This is Kim Jang-hyun.
[기자]
Rekironaju, a COVID-19 treatment made by selecting antibody genes in the blood of cured people.
The Ministry of Food and Drug Safety has decided on conditional approval for this native first treatment.
The treatment targets patients with an underlying disease, mild patients over 60 years of age, and moderately ill patients with symptoms of pneumonia.
It is intended to be used if symptoms appear within a week without oxygen therapy, but it is administered intravenously for 90 minutes.
Since phase 2 clinical trials are for mild and moderate patients, severe patients are excluded from the treatment.
In phase 2 clinical trials, this drug reduced the incidence of severe patients by 54% and shortened the recovery period by more than 3 days.
Based on this, the Final Inspection Committee, which is the final deliberation procedure for permits, determined that the data were faithfully submitted and that there were no problems with safety and effectiveness. Accordingly, it can be used on site immediately after permission.
“It is expected to reduce the morbidity of patients with high-risk mild symptoms and severe morbidity in patients with moderate severity.”
However, expectations and concerns about the effects are intersecting in the medical field.
This is because it is unknown whether this drug will be effective against mutant viruses, and the quarantine authorities are also analyzing the effect.
“Like a vaccine, there is a lot of possibility to be affected by mutants.”
It is an opinion that, as the medical community has required the results of phase 3 tests to be submitted by this year, it is necessary to increase the amount of use and observe the effect.
This is Yonhap News TV Kim Jang-hyun.
Yonhap News TV article inquiries and reports: katok/line jebo23
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