SEOUL, Nov. 12 (Korea Bizwire) — The European Union’s drug agency has recommended the approval of a COVID-19 antibody treatment by Celltrion Inc., paving the way for its sales in the region, the South Korean pharmaceutical giant said Friday.
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency recommended the application of Rekirona in adult patients aged 18 and older.
The European Commission, which is authorized to approve medicines in the region, is expected to issue its decision within two months on the CHMP opinion.
Celltrion is currently conducting a phase three clinical study of Rekirona in 13 countries on 1,315 critically ill COVID-19 patients.
Rekirona is a monoclonal antibody with activity against COVID-19. A monoclonal antibody is a type of protein that has been designed to attach to a specific structure.
It takes the form of an intravenous injection that is directly injected for 60 minutes.
In February, Rekirona won the South Korean drug safety agency’s conditional approval, becoming the first locally made treatment for COVID-19.
The drug won its first overseas approval for an emergency application from Indonesia and Brazil.
Celltrion said Rekirona reduces the risk of progressing to severe COVID-19, compared with patients administered with a placebo. The company said the antibody treatment also reduced the recovery time.