Conditional approval from the Ministry of Food and Drug Safety
Completed production of Celltrion for 100,000 people
Use for high-risk mild and moderate patients
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Celltrion (068270)The novel coronavirus infection (Corona 19) antibody treatment “Recyronaju (ingredient name Regdanvimab)” developed by the company will be put into the medical field. It was the first indigenous COVID-19 treatment to be approved by a regulatory agency. It is the third in the world after Eli Lilly and Regeneron. The prescription target was confirmed as high-risk mild and moderately ill patients, excluding general mild patients that were initially expected.
The Ministry of Food and Drug Safety announced on the 5th that it has decided to conditional approval for Rekirona, an antibody treatment developed by Celltrion after going through the final inspection committee, the last expert advisory meeting for the approval of drugs related to Corona 19. Conditional approval is a system that first permits only drugs that can be expected to have therapeutic effects in a serious illness that threatens safety and submits the results after marketing. Accordingly, from this day on, Celltrion will be able to supply Rekirona if requested by the medical field. The results of phase 3 clinical trials must be submitted by December 31st.
Rekironaju is an antibody treatment based on neutralizing antibodies that bind to the Corona 19 virus and reduce infectivity and toxicity. It is administered by intravenous injection for about 90 minutes, and the dose is 40 mg per 1 kg of the patient’s body weight. As a result of the phase 2 clinical trial, the recovery period of patients receiving Rekirona injection was 5.34 days, which was 3.43 days earlier than 8.77 days in the placebo group. The time to transition from positive to negative was clinically insignificant, and the effect on mortality was unknown. Celltrion has already produced 100,000 people to supply it to the medical field and plans to provide it to Korea at cost. The government plans to quickly determine the application of health insurance for the use of Rekkirona in the future.
However, the prescription target was limited to patients with high risk of Corona 19, mild and moderate. This is because the treatment efficacy was not recognized for general mild patients, which constitute the majority of confirmed cases. High-risk patients with mild symptoms are those aged 60 years or older with mild symptoms, or those with a vascular disease, chronic respiratory disease, diabetes, or hypertension as an underlying disease. Moderately ill patients are patients with COVID-19 who have mild pneumonia rather than severe. The Ministry of Food and Drug Safety explained that “general patients with mild symptoms other than high-risk groups cannot use it in principle, even if they want to use it,” he said.
Meanwhile, the disease authorities responded to some concerns that antibody treatments are powerless against mutant viruses, saying, “We have not yet secured a scientific basis to judge clearly.” Said.
/ Reporter Ji-hye Seo [email protected]
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