Anvisa (National Health Surveillance Agency) approved this Wednesday (8), unanimously, the request for emergency use of a new drug for patients with Covid-19, sotrovimab.
The order was presented by the manufacturer GlaxoSmithKline Brasil, in July this year. The drug is indicated for patients with mild and moderate cases of the disease, but who are at high risk of progression of Covid-19.
Among the high risk factors pointed out by Anvisa are advanced age, obesity, cardiovascular disease, including hypertension, chronic lung disease. In addition to asthma, diabetes, chronic kidney disease, including those on dialysis, chronic liver disease and immunosuppressed.
Treatment can only be started in people aged 12 years and over and weighing at least 40 kg. The use is done in a single dose and should start within 5 days from the onset of symptoms. The application is restricted to hospitals.
Treatment is not indicated for people who need oxygen supplementation. This is because it can be associated with worsening clinical outcome when the patient is in this situation.
Meiruze de Sousa Freitas, reporter of the request for emergency use of the drug, explained that the drug consists of a treatment with a monoclonal antibody that prevents viral entry into the cell and, consequently, infection.
“It’s a monoclonal antibody made in the laboratory that mimics the immune system’s ability to fight the virus. It works against the spike protein of Sars-Cov-2 and is designed to block the virus from binding and entering human cells.”
Gustavo Mendes, general manager of Medicines and Biological Products at Anvisa, explained that clinical studies showed a reduction in the risk of disease progression in 79% of cases.
“It is a result that has an important relevance. A data and a significant outcome in terms of clinical study that shows the favorable performance in reducing the risk of hospitalization and death”.
He added that there are uncertainties as to the actual effectiveness of the product against virus variants. However, in vitro studies do not indicate loss of efficacy.
In addition, use in pregnant women should be done with caution, as there are limited data on the use of the product in this population.
This is the fifth treatment against Covid approved by Anvisa. The first was Remdesivir, which was registered with the agency in March. The other is Regen-cov, which consists of a combination of monoclonal antibodies, approved for emergency use.
In May this year, the agency approved the emergency use of the drug developed by the company Eli Lilly. Treatment is a combination of the biological drugs banlanivimab and etesevimab.
In August of this year, it was the drug regdanvimabe, from the company Celltrion Healthcare. It is indicated for mild to moderate treatment in adults who do not need oxygen supplementation but are at high risk of progression to Covid-19.