Celltrion's COVID-19 Treatment 'Rekkirona' Granted Emergency Use Authorization in Brazil

Emergency Use Authorization Obtained in Brazil Following Indonesia

Celltrion CI (Photo by Celltrion)

[Asia Economy Reporter Kim Ji-hee] Celltrion's COVID-19 antibody treatment 'Rekkirona (generic name Regdanvimab)' received emergency use authorization from the Brazilian Health Regulatory Agency on the 11th local time.

Celltrion submitted the results of phase 1 and phase 2 clinical trials of Rekkirona to the Brazilian Health Regulatory Agency, along with the recently completed global large-scale phase 3 results and preclinical data on the Brazil-origin 'Gamma variant' and India-origin 'Delta variant.' The Brazilian health authorities reviewed the submitted data and announced the emergency use authorization of Rekkirona for adult high-risk mild and moderate COVID-19 patients. At the officials' meeting that day, the emergency use authorization for Rekkirona was unanimously approved by the review committee members.

According to Worldometer, as of the 11th, Brazil's daily confirmed COVID-19 cases reached 35,000. The cumulative confirmed cases are 20.21 million, and the death toll is 564,800. In particular, due to the spread of the Delta variant, new daily cases have sharply increased from the 10,000 range to the 30,000 range recently.

A Celltrion official said, “Based on the safety and efficacy proven through large-scale global clinical data of Rekkirona, we have obtained emergency use authorization from the Brazilian health authorities,” and added, “We will do our best to contribute to preventing the spread of COVID-19 by early supplying Rekkirona to Brazil, where daily confirmed cases have surged to 30,000 due to the spread of the Delta variant.”

This content was produced with the assistance of AI translation services.