Brazil's ANVISA grants EUA for Celltrion's regdanvimab

The Brazilian Health Regulatory Agency (ANVISA) has granted an emergency use authorization (EUA) for South Korea’s Celltrion Healthcare’s (Kosdaq: 068270) monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) for the treatment of adults with mild-to-moderate COVID-19 who do not require supplemental oxygen and who are at high risk of progression to severe COVID.

Brazil had the highest number of confirmed cases from COVID-19 in Latin America with an average of 35,000 cases per day. Since the beginning of the pandemic, at least one in 10 residents have been infected, a total of 20,249,176 reported cases.

“Today’s announcement of emergency use authorization for regdanvimab takes us a significant step closer to providing a safe and effective monoclonal antibody treatment against COVID-19 to patients in Brazil,” said Dr HoUng Kim, head of Medical and Marketing Division at Celltrion Healthcare.