The National Health Surveillance Agency (Anvisa) unanimously approved this Wednesday (8) the emergency use of another drug against Covid-19: the Sotrovimab, a monoclonal antibody, manufactured by GlaxoSmithKline (GSK).
This is the fifth drug approved by the agency.. In March, Anvisa announced the registration of the antiviral remdesivir. Back in April, Regn-CoV2, a cocktail containing a combination of casirivimab and imdevimab, was approved for emergency use in the country.
In May, the agency approved the emergency use of the association of the antibodies banlanivimab and etesevimab, a drug produced by pharmaceutical company Eli Lilly. Last month it was the turn of Regkirona (regdanvimabe).
The request for emergency use was made on the 19th of July.
What is the drug and how will it be administered:
- A single-dose monoclonal antibody that targets the SARS-CoV-2 S spike protein, thus preventing virus entry and infection of human cells;
- The treatment is indicated for adults and children over 12 years old (who weigh at least 40 kg), who do not need oxygen supplementation;
- It is not recommended for critically ill patients;
- Treatment should be started as soon as possible. after positive viral test for SARS-CoV-2 and within 5 days of symptom onset;
- Use restricted to hospitals, under medical prescription and its sale is prohibited to trade;
- Prohibited sale to commerce;
- It does not replace Covid-19 vaccines.
THE application is intravenous, with a restricted single dose 500 mg of sotrovimab and treatment should be started after a positive Covid-19 viral test and within 5 days of symptom onset. Use is restricted to hospitals and sale is prohibited to commerce. The incorporation in the Unified Health System (SUS) depends on the evaluation of the Ministry of Health.
Risk factors also exist when using the drug in elderly individuals who have cardiovascular disease or chronic lung disease, type 1 or type 2 diabetes mellitus, chronic kidney disease, chronic liver disease, or people who are currently receiving immunosuppressive treatment.
According to Anvisa, the use in pregnant women should be done with caution., since there are limited data on the use of the product in this population.
In March, Anvisa announced the registration of the first drug for hospitalized patients with Covid-19, the antiviral redevive.
- Remedy: understand what is the experimental antiviral
Remdesivir is produced by the biopharmaceutical Gilead Sciences and its trade name is Veklury. It is a synthetic medicine given intravenously (injected into a vein). It works by preventing viral replication.
The general manager of Medicines and Biological Products at Anvisa, Gustavo Mendes, clarified that remdesivir is not sold in a pharmacy and can only be used under medical supervision. “It is restricted use of hospitals so that patients can be properly monitored,” he said.
Remdesivir: what we already know about the only medicine registered in Brazil to treat Covid
In April, another drug was approved on an emergency basis. It is a cocktail that contains the combination of casirivimab and imdevimab (Regn-CoV2), two experimental remedies developed by pharmaceutical Roche.
- Regn-CoV2: understand what the antibody cocktail is
“These products are what we call monoclonal antibodies. The idea behind this proposal is to neutralize the virus so that it does not spread in infected cells and thus control the disease”, explained the general manager of medicines and biological products, Gustavo Mendes.
Regn-CoV2 has already been approved for emergency use by the FDA, the US health agency, after showing good results in patients with mild and moderate symptoms of Covid-19. It was also used in the treatment of former US President Donald Trump.
Regn-Cov2: understand the cocktail of antibodies against Covid-19 approved by Anvisa
- Banlanivimab and Etesevimab: understand how monoclonal antibodies work
In May, Anvisa approved the emergency use of the combination of two monoclonal antibodies, Banlanivimab and Etesevimab. Antibodies are laboratory versions of the body’s natural defenses designed to fight infections.
According to Anvisa, the treatment is indicated for adults and pediatric patients (aged 12 or over who weigh at least 40 kg) who do not need oxygen supplementation, with laboratory-confirmed SARS-CoV-2 infection and who are at high risk of progression to severe Covid-19.
The drug is not recommended for severely ill patients. “Monoclonal antibodies such as banlanivimab + eteasevimbe may be associated with worsening clinical outcomes when administered to patients hospitalized with Covid-19 who need high-flow oxygen supplementation or mechanical ventilation”, warns Anvisa.
- Regkirona (regdanvimab): see what the medicine is
Anvisa approved the emergency use of regdanvimab In August. In the body, this type of medicine helps in the reproduction of antibodies that help fight a specific disease. However, the use of the drug does not prevent the disease.
Regdanvimab is not recommended for critically ill patients. Its use is restricted to hospitals and sale is prohibited to commerce.
According to the agency, there are risks regarding the use of the drug in the elderly and obese people. There are still no data on use in pregnant women, nursing mothers, patients with moderate or severe liver disease, and patients with severe kidney disease.