This undated photo, provided by South Korean pharmaceutical giant Celltrion Inc., shows Rekirona.
SEOUL, Jan. 14 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Friday its COVID-19 antibody treatment has won temporary approval from Swedish authorities.
Swissmedic granted Temporary Authorization of Rekirona for adult COVID-19 patients who do not require supplementary oxygen treatment and are at high risk of developing into severe cases.
The approval will be valid for two years, Celltrion said.
Celltrion conducted a phase three clinical study of Rekirona in 13 countries on 1,315 critically ill COVID-19 patients.
According to top-line results from the clinical study, Rekirona sharply reduced recovery time and the chance of a severe case, showing both efficacy and safety.
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 overseas approval for an emergency application by the European Medicines Agency. It has also been granted emergency use authorizations in Indonesia, Brazil, Peru and Australia.
(Yonhap)
