SEOUL, June 14 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Monday that its COVID-19 antibody treatment has sharply reduced recovery time and the chance of a severe case.
Celltrion announced top-line results from a global phase three clinical study of Rekirona, a pivotal part of the study to obtain more comprehensive safety and efficacy results.
Rekirona won the South Korean drug safety agency’s conditional approval in February, becoming the first locally made treatment for COVID-19.
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.
The drug already has won approval for an emergency application in many countries.
Celltrion said Rekirona reduces the risk of progressing to severe COVID-19 by 54 percent, compared with patients administered with a placebo.
The company said the antibody treatment also reduced the recovery time by an average of 4.9 days among all COVID-19 patients and 4.7 days among severe COVID-19 patients.
The company plans to submit an application for the formal authorization to the U.S. Food and Drug Administration (FDA) and to the European Medicines Agency (EMA) in the coming months.