Expectations for Celltrion Treatment with '54% Reduction in Severe Cases'

Time Taken Until Symptoms Disappear
Rekkironaju Administration Takes About 5 Days
Prime Minister Jeong Expects Approval in Early February

[Image source=Yonhap News]

[Asia Economy Reporter Choi Dae-yeol] Interest is growing in whether the antibody treatment for the novel coronavirus infection (COVID-19) developed by Celltrion can help reduce the burden on frontline medical staff as some clinical trial results have been disclosed.

Although Phase 3 clinical trials remain and the current results limit its use to certain high-risk groups, the treatment has shown some effectiveness in preventing patient conditions from worsening and reducing hospitalization duration, suggesting it will be useful when necessary. It is expected to take nearly a year at the earliest to reach herd immunity through vaccination, so this treatment could also help in managing hospital bed capacity.

According to the global Phase 2 clinical trial results of "Rekkironaju" (generic name Regdanvimab·CT-P59) released by the company on the 13th, the incidence of severe cases requiring hospitalization was reduced by 54%. For those aged 50 and above, the reduction was about 68%. The trial involved 307 patients with mild to moderate symptoms, and the group receiving the drug had about half as many patients whose condition worsened compared to the placebo group. The time taken for symptoms to disappear was 5.4 days in the Rekkironaju group and 8.8 days in the placebo group, showing a reduction of over 3 days with Rekkironaju. The effect of shortening recovery time was greater in patients with relatively worse symptoms or older age. There were no serious adverse reactions, deaths, or study discontinuations due to adverse reactions during the trial.

Professor Eom Jung-sik of the Department of Infectious Diseases at Gachon University Gil Medical Center, who led the clinical trial, said, "We have proven through the trial that administering the drug to patients with mild to moderate symptoms significantly lowers the rate of progression to severe cases while enabling faster recovery," adding, "Vaccines as well as treatments are essential options to prevent the spread and worsening of the COVID-19 pandemic."

Prime Minister Chung Sye-kyun appeared on TBS Radio on the same day and said regarding the approval review of Rekkironaju, "We expect the approval to be granted around early February," and added, "A treatment that prevents mild patients from progressing to severe cases will be very helpful."

The company has applied for conditional approval to allow frontline patients to use the drug before completing the final clinical trials. The Ministry of Food and Drug Safety plans to hold a verification advisory committee meeting composed of infectious disease and related experts on the 17th to review the clinical data submitted by the company. This process will assess whether the indicators used to gauge effectiveness, such as fever and symptoms, and the drug's mechanism of action are appropriate to recognize its therapeutic effect. There are still many steps to go through, including the Central Pharmaceutical Affairs Committee and the final inspection committee.

This content was produced with the assistance of AI translation services.