Celltrion’s Regkirona gets EUA for limited use in Brazil

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Celltrion’s Regkirona gets EUA for limited use in Brazil

Published: 12 Aug. 2021, 15:48 Updated: 12 Aug. 2021, 19:12

Celltrion's Covid-19 treatment Regkirona [CELLTRION]

Celltrion’s Regkirona Covid-19 treatment has received an emergency use authorization (EUA) from regulators in Brazil.

According to the company on Thursday, the Brazilian Health Regulatory Agency said Wednesday that it approved the emergency use of Regkirona for high risk Covid-19 patients with moderate and light symptoms.

Celltrion submitted the results of all three clinical trials, as well as the preclinical trials conducted to test the treatment’s efficacy against Brazil’s Gamma and India’s Delta variants.

In July, Celltrion won the EUA for the use of the Regkirona Covid-19 treatment in Indonesia. The Korean company has also applied for EUAs for Regkirona in many countries, including Malaysia, Saudi Arabia, India and Mexico, according to multiple media outlets.

"With Regkirona’s effectiveness and safety, it was able to win emergency use authorization from health regulators in Brazil,” said a spokesperson for Celltrion. “Celltrion will contribute to prevent the further spread of Covid-19 by supplying Regkirona in Brazil in which the daily new cases have been surging to the 30,000 level.”

According to data from Worldometer, the number of Covid-19 cases in Brazil totaled 20.25 million as of 2 p.m. Thursday. The number of deaths totaled 566,013. The daily Covid-19 cases rose to about 30,000-level due to the spread of the Delta variant.