Brazil’s health regulator authorizes emergency use of antibody cocktail against Covid-19

RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (ANVISA) unanimously approved on Tuesday, April 20th, the emergency use of the monoclonal antibodies cocktail against Covid-19, produced by the company Regeneron and marketed by pharmaceutical company Roche.

It is the second drug against Covid-19 approved by ANVISA for use in Brazil. The first was remdesivir, on March 12th this year. The cocktail called REGN-COV2 contains a combination of the experimental monoclonal antibodies casirivimab and imdevimab.

The drug is administered intravenously, its use is restricted to hospitals, and sale is prohibited. The drug does not replace the Covid-19 vaccine and does not serve to prevent the disease.

According to ANVISA, the treatment is indicated for mild or moderate cases of Covid-19 in adults and children – aged 12 years or older who weigh at least 40 kg – who do not require oxygen supplementation and are at high risk of progression to a severe case.

According to Gustavo Mendes Lima Santos, ANVISA’s general manager of Biological Medicines and Products, REGN-COV2 showed a substantial reduction in the number of hospitalized patients and deaths in the case of symptomatic infected patients and those with a comorbidity, besides presenting a significant decrease of viral load in patients.

The agency warned that the drug should not be used in patients in critical condition. “Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worsening clinical outcomes when administered to hospitalized patients with Covid-19 who require high-flow oxygen supplementation or mechanical ventilation.”

The risk factors considered for the indication of the drug are: advanced age (65 years or older), obesity, cardiovascular disease, hypertension, chronic lung disease, asthma, diabetes, chronic kidney disease, including immunosuppressed dialysis patients, and chronic liver disease.

In the case of authorization in Brazil, the dose is 600 mg of each drug, which must be administered together and by means of a single intravenous infusion (through a bag, similar to the administration of a serum, for example).

Santos pointed out that the treatment has undergone four separate non-clinical studies, in which no “major issues” were identified regarding safety, and considered to have an “acceptable” profile. “The trials did not generate concerns that would justify a specific investigation,” he noted.

The benefit would be perceptible from the second day after administration. According to the study considered by ANVISA, there was a 70.4% reduction in the number of patients hospitalized with Covid-19, when compared to the group that received placebo.

The agency also stressed that patients receiving treatment with the drug should wait at least 90 days to be vaccinated against Covid-19, after seeking medical evaluation.

The American TV station CBS estimated that the cost of treatment with Regeneron’s cocktail in the U.S. can vary between US$1,500 and US$6,500 (up to R$35,807, in direct conversion). In Brazil, the price will be defined by CMED (Office for Medicine Market Regulation).

The cocktail has already been approved for emergency use in the United States, Canada, and Switzerland. It has also been recommended for use by the European Medicines Agency. The drug also became known for being used in former U.S. President Donald Trump’s treatment against Covid-19 in October last year.

The drug has a shelf life of 12 months when stored at 2°C to 8°C. When diluted, it can be stored for up to four hours at room temperature and, if refrigerated, for up to 36 hours.

Source: Exame