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(LEAD) Celltrion's COVID-19 antibody treatment wins conditional approval in Australia

National 10:07 December 07, 2021

(ATTN; UPDATES with more info in paras 4-6)
By Kim Han-joo

SEOUL, Dec. 7 (Yonhap) -- South Korean pharmaceutical giant Celltrion Inc. said Tuesday its COVID-19 antibody treatment has won conditional approval from Australian authorities.

The Therapeutic Goods Administration (TGA) granted provisional approval of Rekirona for the intravenous treatment of mild-to-moderate COVID-19 in adult patients.

It is the fifth COVID-19 treatment to receive regulatory approval in Australia.

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

The TGA said continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

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 and Peru.

Celltrion said Rekirona reduces the risk of COVID-19 progressing to severe levels. The company said the antibody treatment also reduced the recovery time.


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