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| Medical staff are collecting specimens at a temporary screening clinic in Seoul Station Square on the 13th, where 562 new cases of the new coronavirus infection (Corona 19) were recorded and 500 were maintained for two consecutive days. 2021.1.13/News1 © News1 Reporter Sungcheol Lee |
Celltrion’s novel coronavirus infection (Corona 19) antibody treatment’Recyrona’ has been shown to reduce the incidence of critically ill patients, raising the possibility of commercialization in Korea this February. With conditional approval, it is expected to have an efficient weapon capable of responding to COVID-19 along with vaccines purchased overseas.
According to the Ministry of Food and Drug Safety on the 14th, Celltrion’s Rekkirona approval review is in progress beyond the 7th ridge. Previously, clinical data review, production facilities, and clinical trial institution surveys were conducted, and the external expert advisory group meeting will begin next week.
In general, treatment approval/examination procedures are conducted in the following order:’receipt of application for permission → preliminary review → review and investigation → consultation → approval’. In light of this, Celltrion’s Rekkirona screening stage shows that only the last gateway, the advisory stage, is left behind.
In particular, as the Ministry of Food and Drug Safety has operated a rapid review program within 40 days to support medical sites that do not have a suitable alternative to use patient treatment, it is expected that approval will be issued under the condition of conducting a phase 3 clinical trial as early as January or early February. do.
According to the results of Rekirona’s Phase 2 clinical trial, it was found that it will contribute to the reduction of deaths by suppressing the outbreak of severely ill patients, which is currently the most problematic in the world. It is expected that patients with mild and moderate symptoms will recover faster, thereby solving the problem of shortage of medical beds.
“Phase 3 must be carried out, but first of all, this result will open new effects in the treatment of high-risk groups over 50 years old in the medical field,” said Um Joong-sik, a professor of infectious medicine at Gachon University Gil Hospital, who led the clinical trial. “Reducing the burden of medical institutions, “It can give you a lot of room to treat patients with moderate to high risk,” he said.
This clinical trial is the result of completing the final medication on November 25 last year (24 days overseas local time) with a total of 327 patients participating in Korea, Romania, Spain and the United States. The actual data analysis included 307 patients, and moderately ill patients with pneumonia accounted for about 60% of the total.
The research team conducted the experiment by dividing the Rekirona group and the sham drug group. As a result of observing the progress for 28 days, the incidence of developing severe disease in 54% of all patients in the Rekirona group decreased compared to the placebo group.
It was found that 68% of the patients with moderate illness over the age of 50, which are prone to severe worsening, had severe incidence suppressed. The patient’s symptom recovery period after administration was also faster than that of the placebo group. The time to show clinical recovery was 5.4 days in the Rekirona injection group, 3.3 days shorter than the 8.8 days in the placebo group.
In addition, in patients with moderate or severe symptoms over 50 years of age, the time it takes for clinical recovery to show clinical recovery when taking Rekironaju was shortened by more than 5-6 days compared to the placebo group. The virus reduction rate also reached the 7th day of the treatment group after the 10th day in the placebo group.
Celltrion plans to conduct phase 3 clinical trials in more than 10 countries around the world and further verify the safety and efficacy of Rekirona strain confirmed in phase 2 clinical trials in a wider range of patients. Along with this, it is also applying for emergency use approval of Rekkirona to US and European health authorities.
When Rekkirona receives a conditional license in Korea, it is expected to be used in quarantine activities along with the Corona 19 vaccine, which is scheduled to be introduced overseas in February. The quarantine authorities can reduce the burden of the medical system with treatments, and vaccines can reduce the number of confirmed cases, thereby establishing an efficient response system beyond social distancing and masks.
Celltrion officials said, “If we receive conditional approval from the Ministry of Food and Drug Safety, we have already finished producing 100,000 people and are thoroughly preparing a supply plan so that we can supply them to the medical field immediately.” The plan is also systematically prepared.”