Home » Business » [비즈헬스] Celltrion opens the era of’domestic Corona 19 treatment’… Conditional approval of antibody treatment’Rekirona’

[비즈헬스] Celltrion opens the era of’domestic Corona 19 treatment’… Conditional approval of antibody treatment’Rekirona’

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Celltrion’s’Rekironaju’ was born as the first domestic COVID-19 treatment. Photo = Celltrion


[비즈월드] Celltrion’s COVID-19 antibody treatment,’Recyronaju (ingredient name Legdanvimab)’ has opened the era of the domestic Corona 19 treatment.

According to related industries and Celltrion, the Ministry of Food and Drug Safety approved the conditional product approval of Rekkirona on the afternoon of the 5th. The targets of this treatment are adult patients with mild or moderate symptoms in high risk for COVID-19.

Celltrion started developing Rekkirona after the spread of Corona 19 last year. It completed a phase 2 clinical trial in November 2020, and applied for conditional approval from the Ministry of Food and Drug Safety at the end of December. As a result of the global phase 2 clinical trial conducted by Celltrion, there were no serious adverse reactions or deaths, and efficacy was confirmed across several evaluation indicators.

Rekironaju is a severe patient requiring inpatient treatment, and the probability of worsening the disease was reduced by 54% in all patients compared to the placebo group who received standard treatment only, and 68% in the moderately ill patients over 50 years of age with pneumonia.

In particular, the time required for patients to show clinical recovery was 3.4 days compared to the placebo group in all patients, 5.1 days in the moderately ill patients with pneumonia, and 6.4 days in the moderately ill patients over 50 years old with pneumonia.

As officially announced, the Ministry of Food and Drug Safety quickly reviewed the state of Rekkirona. In the end, it was approved on the 5th by receiving advice from the’triple meeting’ of the verification advisory group composed of experts, the central pharmacy review committee and the final inspection committee.

It was only conditional permission. The verification advisory group recommended the approval of Rekirona for the administration of mild and moderate patients, but the Central Pharmacy Review Committee and the Final Inspection Committee recommended that the range of mild patients be limited to high-risk groups.

Accordingly, the Ministry of Food and Drug Safety conditionally approved the state of Rekkirona. Although the main data necessary for the review have been faithfully submitted and there is no problem with safety and effectiveness, Rekironaju is prescribed for high-risk patients who are over the age of 60 or have one or more of cardiovascular disease, chronic respiratory disease, diabetes, and high blood pressure.

An official from Celltrion said, “All Celltrion executives and employees have worked with one heart for the past year under the mission of fulfilling their social responsibilities, resulting in this result.” “We will do our best to accelerate it drastically and minimize the incidence of severe patients that can lead to death.”

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