Celltrion Antibody Treatment 'Rekkironaju' Used in Europe

Celltrion's COVID-19 antibody treatment 'Rekkironaju'
[Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] Celltrion's COVID-19 antibody treatment 'Rekkirona-ju' (Regdanvimab·CT-P59) has received a recommendation for use within Europe.

On the 26th (local time), the European Medicines Agency (EMA) announced that its subsidiary committee, the Committee for Medicinal Products for Human Use (CHMP), recommended the use of Celltrion's COVID-19 antibody treatment Rekkirona-ju.

Through a summary of the CHMP decision posted on its website, the EMA stated that the CHMP recommended Rekkirona-ju "for adult COVID-19 patients who do not require oxygen therapy and are at high risk of progressing to severe disease." The EMA explained that this review was conducted to provide scientific opinions to assist individual countries in deciding on the potential use of Rekkirona-ju prior to marketing authorization.

It also announced that the rolling review of this treatment, which began on the 24th of last month, is currently ongoing. The rolling review is a procedure designed to expedite the evaluation of medicines or vaccines during public health emergencies such as COVID-19. This rolling review will serve as the foundation for future applications for EU marketing authorization of this drug.

The EMA noted that preliminary results from ongoing study data suggest that Rekkirona-ju may reduce hospitalization rates, but also stated that these results are not yet strong enough at this stage to reach a definitive conclusion.

Celltrion's antibody treatment Rekkirona-ju received conditional approval as the first COVID-19 treatment in Korea on the 5th of last month and is being supplied to medical institutions nationwide. As of the 24th, it has been administered to 681 patients at 48 hospitals.

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