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Celltrion's COVID-19 antibody treatment wins emergency approval in Brazil

All News 09:27 August 12, 2021

By Kim Han-joo

SEOUL, Aug. 12 (Yonhap) -- South Korean pharmaceutical giant Celltrion Inc. said Thursday that its COVID-19 antibody treatment has won an emergency approval from Brazilian authorities.

The Agencia Nacional de Vigilancia Sanitaria granted the approval for an emergency application of Rekirona in adult COVID-19 patients at high risk, Celltrion said.

The approval was based on recent 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.

This undated photo, provided by South Korean pharmaceutical giant Celltrion Inc., shows Rekirona. (PHOTO NOT FOR SALE) (Yonhap)

Celltrion is conducting the 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.

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.

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.

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) upon the release of the interim outcome its phase three clinical trial.


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