On the 26th (local time), the European Medicines Agency (EMA) announced that the Korean biopharmaceutical manufacturer Celltrion’s new coronavirus infection (Corona 19) antibody treatment’Rekyronaju’ (regdanvimab CT-P59) did not require oxygen therapy and was severely severe. Reuters reported that it can be used for the treatment of COVID-19 in adult patients who are at high risk of progressing to.
EMA said the review was conducted to provide scientific opinions to help individual countries make decisions about the possible use of the drug prior to marketing approval. The Rolling Review, which began on the 24th of last month, said It said that it is currently in progress.
The companion review is a procedure to quickly evaluate promising drugs or vaccines in public health emergencies such as the global epidemic of COVID-19.
The companion review will serve as the basis for future applications for EU marketing approval.
EMA said the results of the first section of ongoing study data suggest that Rekirona may lower hospitalization rates, but added that the results are not strong enough to reach definitive conclusions about the benefits of the drug at this stage.
Nonetheless, EMA explained that the EMA’s Drug User Advisory Committee (CHMP) concluded that the treatment could be considered a treatment option for patients at high risk of developing severe COVID-19.
Celltrion’s antibody treatment, Rekironaju, is being supplied to medical institutions nationwide with conditional approval from the Ministry of Food and Drug Safety as the’Korean No. 1’Corona 19 treatment.
/yunhap news
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