[단독]EMA “Celltrion Rekirona State, Available for Emergency Use Before Permit in Europe”

[이데일리 왕해나 기자] The European Medicines Agency (EMA)’s Drug User Advisory Committee (CHMP) recommended that the Corona 19 antibody treatment “Rekironaju” can be used as a treatment option for patients at high risk of developing severe Corona 19.

Celltrion Rekironaju. (Photo = Celltrion)

According to the EMA website on the 26th, CHMP has completed a review of the use of Rekirona for the treatment of patients with COVID-19. EMA made recommendations after reviewing data on the effects of Rekironazu in mild to moderate COVID-19 patients who did not require oxygen therapy.

“The first part of the study indicates that Rekirona can lower hospitalization rates,” EMA explained. “These results are not robust enough to reach solid conclusions at this point in time.” “Most side effects reported from a safety standpoint were mild,” he said. “Reactions related to drug injection (including allergic reactions) cannot be ruled out, and medical staff should monitor patients for these reactions.”

“Despite this uncertainty, CHMP concluded that Rekyrona could be considered a treatment option for patients at high risk of developing COVID-19 based on the reasonable likelihood and low risk that the drug could provide a clinical benefit. I built it. As a result, Celltrion will be able to supply Rekirona products to countries in Europe prior to formal approval.

This is a separate process from the rolling review (sequential review) launched by EMA last month. In Europe, the review of Rekkirona is being conducted as a rolling review-to-track, which is used to accelerate the evaluation of promising treatments or vaccines in crisis situations such as emergency use and pandemic before approval.

Rekkironaju, the first Korean-made Corona 19 treatment, received conditional approval from the Korean Ministry of Food and Drug Safety at the beginning of last month. As of the last 25 days, it was administered to 681 patients in 48 hospitals.