Celltrion's COVID-19 tx is approved for sale in Europe

European Commission approves the sales license

It is the first new antibody drug developed in Korea to enter Europe

Regkirona, a COVID-19 antibody treatment developed by Celltrion, has been approved in Europe.

 

Celltrion announced on the 15th that the EC approved Regkirona on the 12th (local time) for the final sale for the purpose of treating COVID-19.

 

Regkirona has been approved for the treatment of adult patients aged 18 or older who have been confirmed with COVID-19 who do not require oxygen supply and are likely to be severely transmitted.

 

It is a single administration of 60 minutes intravenously, the same as domestic item permission.

 

Regkirona officially received an item license from the EC a day after obtaining an approval recommendation from the CHMP under the European Medicines Agency (EMA) on the 11th.

 

Celltrion said, "If CHMP usually recommends approval for new drug approval, EC's final item approval will be completed 1-2 months later, but in this case, official item approval continued in a day," and explained, "It can be interpreted as an EC-level effort to quickly cope with the surge in the number of COVID-19 confirmed cases in Europe." Regkirona is the first new antibody drug developed in Korea to obtain an official item license in Europe.

 

Regkirona obtained emergency approval from the BPOM and the ANVISA in July and August, and in September, it obtained a formal item license from the MFDS in Korea.

 

Regkirona is administered to 22,587 patients in 129 hospitals as of the announcement of Central Disaster and Safety Counters Headquaters (CDSCHQ) on the 12th and is actively used to treat COVID-19 patients in Korea.

 

Regkirona confirmed the safety and effectiveness of the global phase 3 clinical results conducted on 1,315 mild and moderate COVID-19 patients in 13 countries around the world, including Korea, the United States, Spain, and Romania.

 

In the high-risk group of patients administered Regkirona, the incidence of severe patients decreased by 72% compared to the placebo group, and the clinical symptom improvement time was also reduced by more than 4.7 days compared to the placebo group in the high-risk group.

 

An official from Celltrion said, "We will do our best to help many COVID-19 patients in Europe benefit from Regkirona's proven safety and effectiveness, and to contribute to the end of the global COVID-19 crisis."