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Celltrion, a South Korean pharmaceutical company, revealed on Thursday, Aug. 12, that it has received emergency approval from the government of Brazil for its COVID-19 antibody treatment.
According to The Korea Herald, Celltrion shared that the Health Regulatory Agency of the said country granted emergency use authorization (EUA) for its Regkirona or CT-P59, which is a COVID-19 treatment. It was said that the agency made the decision based on the results of the drug’s clinical tests for all three phases.
Celltrion added that the Brazilian health agency also looked into their preclinical studies that show the efficacy of the treatment against COVID-19 variants. Once it is made available in Brazil, Regkirona will be utilized for the treatment of adult patients who are at higher risk from COVID-19 and experiencing both mild and severe symptoms.
Korea Biomedical Review reported that adults aged 65 or older with mild and moderate symptoms would also be treated with Celltrion’s antibody drug. With the high number of daily coronavirus cases in Brazil today, Celltrion said it will deliver Rekirona to the country as fast as it could to help treat the patients.
In the COVID-19 world statistics on Worldometer, Brazil has more than 20 million cases of coronavirus infection and more than 560,000 deaths. With the spread of the more contagious Delta variant, the country is recording daily cases of around 10,000 to 30,000.
“Based on the safety and efficacy proven through large-scale global clinical data of Regkirona, the company has obtained emergency use approval from the Brazilian health authorities,” a Celltrion official stated. “We will do our best to contribute to preventing the spread of Covid-19 by supplying Regkirona early to Brazil, where the number of confirmed cases has recently rapidly increased to 30,000 a day due to the spread of the Delta variant.”
Celltrion declared that its Rekirona antibody treatment drug could reduce the risk of the coronavirus infection from progressing to a severe stage. The pharmaceutical firm further said that it could lessen the recovery time as well. Meanwhile, with the Brazilian EUA, Celltrion is planning to submit an application for similar authorization in the U.S.
