Authorization to administer celltrion antibody therapy to elderly-high-risk patients before approval for phase 3: Dong-A Science

75 researchers from 35 medical institutions participated… Conducted in consultation with the KFDA

75 researchers from 35 medical institutions participated… Conducted in consultation with the KFDA

[연합뉴스 자료사진]

Celltrion-developed antibody treatments are given first to elderly and high-risk patients suffering from novel coronavirus infection (Corona 19).

At a regular briefing on the 14th, the Central Defense Countermeasures Headquarters (Daebon Bang) conducted a clinical trial for researchers with these contents prior to the conditional approval of Phase 3 clinical trials regarding Celltrion’s antibody treatment “Rekyronaju” (ingredient name Regdanvimap, code name CT-P59). He said he would proceed.

Celltrion has applied for conditional approval for phase 3 clinical trials of Rekirona to the Ministry of Food and Drug Safety, and announced the results of phase 2 clinical trials on the previous day that Rekirona has reduced the incidence of severe patients by 54%.

The National Institute of Infectious Diseases plans to conduct a clinical trial for researchers who administer treatments to patients with high age and high risk at the judgment of medical staff even before approval of conditional approval.

This study, which is conducted under consultation with the Ministry of Food and Drug Safety, will involve 75 researchers from 35 medical institutions with the cooperation of the Korean Society of Infectious Diseases.

Kwon Joon-wook, head of the 2nd vice president of Bang Dae-bon, explained that this study is “investigator-led clinical” and “a part that is made according to the subjective judgments of each researcher, such as various clinical results and trust in a specific company’s treatment.”

He added, “Regarding the emergency use approval of the Ministry of Food and Drug Safety for medical and scientific reasons, examination and deliberation are in progress.”

yunhap news

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