It prevents the virus from entering cells before infection takes hold
Em um momento em que a ciência busca ampliar suas ferramentas contra a pandemia, a Anvisa aprovou por unanimidade o sotrovimabe — um anticorpo monoclonal desenvolvido para interceptar o SARS-CoV-2 antes que ele se aprofunde no organismo. A decisão, tomada em setembro de 2021, beneficia pacientes com COVID-19 leve a moderada que carregam fatores de risco para agravamento, oferecendo uma janela terapêutica de cinco dias após o início dos sintomas. Com uma redução de 79% no risco de progressão da doença observada em ensaios clínicos, o Brasil amplia seu arsenal além das vacinas, reconhecendo que proteger a vida exige múltiplas frentes de ação.
- A corrida contra o agravamento da COVID-19 ganha um novo aliado: o sotrovimabe bloqueia a entrada do vírus nas células antes que a doença escape do controle.
- A aprovação é precisa em seus limites — apenas pacientes a partir de 12 anos, com pelo menos 40 kg e fatores de risco definidos podem receber o tratamento, e somente dentro dos primeiros cinco dias de sintomas.
- Uma contradição clínica impõe cautela: pacientes que já necessitam de oxigênio estão excluídos, pois evidências sugerem que o medicamento pode piorar o quadro nessa fase.
- Dúvidas persistem sobre a eficácia contra variantes emergentes e a segurança em gestantes, deixando questões abertas mesmo diante de um avanço significativo.
- O sotrovimabe se torna o quinto tratamento autorizado pela Anvisa, consolidando uma estratégia terapêutica que reconhece a pandemia como um problema que exige respostas em camadas.
A Anvisa aprovou por unanimidade, em setembro de 2021, o uso emergencial do sotrovimabe, um anticorpo monoclonal fabricado pela GlaxoSmithKline Brasil. O pedido havia sido submetido em julho, e a decisão veio sem votos contrários. O medicamento representa uma abordagem elegante: engenheirado em laboratório para imitar a resposta imune natural, ele se liga à proteína spike do SARS-CoV-2 e impede que o vírus invada as células humanas.
O tratamento é destinado a um grupo específico — pessoas com COVID-19 leve a moderada que enfrentam risco real de agravamento. Isso inclui idosos, pessoas com obesidade, doenças cardíacas, hipertensão, condições pulmonares crônicas, diabetes, doenças renais ou hepáticas e imunossupressão. A dose única é administrada em ambiente hospitalar e deve ocorrer dentro de cinco dias do início dos sintomas. Pacientes que já necessitam de suporte de oxigênio estão excluídos — evidências indicam que o medicamento pode ser prejudicial nessa fase.
Os dados clínicos são expressivos: 79% de redução no risco de progressão da doença, o que se traduz diretamente em menos hospitalizações e mortes. Ainda assim, a aprovação carrega incertezas. A eficácia contra variantes emergentes permanece uma questão aberta, e o uso em gestantes exige avaliação cuidadosa diante da escassez de dados de segurança.
Com essa aprovação, o Brasil chega ao seu quinto tratamento autorizado contra a COVID-19, ao lado de remdesivir, Regen-Cov, bamlanivimabe com etesevimabe e regdanvimabe. Cada um representa uma ferramenta distinta para clínicos que atuam naquela janela crítica — antes que a doença grave se instale.
Brazil's health regulator gave the green light on Wednesday to a new weapon against COVID-19. The Anvisa, the country's national health surveillance agency, unanimously approved sotrovimab for emergency use—a monoclonal antibody treatment designed to stop the virus before it gains a foothold in the body. GlaxoSmithKline Brasil, the drug's manufacturer, had submitted the request in July, and the decision came through without dissent.
The drug targets a specific population: people with mild to moderate COVID-19 who face a genuine risk of the disease worsening. That means older adults, people living with obesity, those with heart disease or high blood pressure, chronic lung conditions, asthma, diabetes, kidney disease (including those on dialysis), liver disease, or compromised immune systems. The treatment is available only to patients aged 12 and older who weigh at least 40 kilograms. It comes as a single dose, delivered in a hospital setting, and must be given within five days of symptom onset. There is one hard boundary: patients already requiring oxygen support cannot receive it, because evidence suggests the drug could actually worsen outcomes in that situation.
How it works is elegant in its simplicity. The drug is a laboratory-engineered antibody that mimics what a healthy immune system does naturally—it recognizes the enemy and blocks it. Specifically, sotrovimab targets the spike protein of the SARS-CoV-2 virus, preventing the pathogen from attaching to and entering human cells. Meiruze de Sousa Freitas, the Anvisa official who reviewed the application, described it as an artificial antibody designed to intercept the virus at the moment of invasion. Gustavo Mendes, the agency's head of medicines and biological products, pointed to the clinical trial data: a 79 percent reduction in the risk of disease progression. That is not a marginal improvement. It translates directly into fewer hospitalizations and fewer deaths.
But the approval comes with caveats. Uncertainties linger about how well the drug performs against emerging variants of the virus. In-vitro studies—tests conducted in laboratory conditions—have not shown a loss of effectiveness, but real-world performance against new strains remains an open question. Pregnant women present another gray area. The data on sotrovimab's safety in pregnancy is limited, so use in that population requires careful consideration and medical judgment.
This approval marks the fifth COVID-19 treatment the Anvisa has authorized. Remdesivir arrived first, gaining approval in March. Regen-Cov, a combination of monoclonal antibodies, followed. In May, the agency approved a treatment from Eli Lilly combining two biologics: bamlanivimab and etesevimab. Most recently, in August, regdanvimab from Celltrion Healthcare received the green light for mild to moderate cases in adults not requiring oxygen but at high risk of progression. Each represents a different approach, a different tool in the toolkit. Sotrovimab joins them as another option for clinicians treating patients in that critical window before severe illness takes hold.
Citas Notables
An artificial antibody that blocks the spike protein and prevents viral entry into human cells— Meiruze de Sousa Freitas, Anvisa official
A 79 percent reduction in disease progression risk, showing favorable performance in reducing hospitalization and death— Gustavo Mendes, Anvisa head of medicines and biological products
La Conversación del Hearth Otra perspectiva de la historia
Why does this drug only work in the first five days? What happens after that?
The virus is moving fastest in those early days—it's still replicating in the upper respiratory tract, still vulnerable to being blocked before it spreads deeper into the lungs. After five days, the infection has usually progressed too far for an antibody to intercept it effectively.
The 79 percent reduction in progression—that's the number everyone will remember. But what does progression actually mean here?
It means hospitalization, severe respiratory distress, death. The drug doesn't cure COVID; it prevents the disease from getting bad enough to require intensive care. For someone at high risk, that's the difference between staying home and ending up in a hospital bed.
Why can't they give it to people already on oxygen?
That's the counterintuitive part. In those patients, the drug seemed to make things worse, not better. The mechanism isn't entirely clear, but the data was clear enough that they had to draw a line.
So this is really for a narrow slice of people—sick enough to need treatment, but not sick enough to be hospitalized yet.
Exactly. It's for that moment when someone knows they're in trouble but still has time. The trick is catching them in that window.
What about the variants question? Does this drug work against Omicron, Delta, all of them?
That's the honest uncertainty. Lab tests suggest it should, but we won't know for certain until it's used widely against each new variant. That's why they approved it—the benefit was clear enough to move forward despite the unknowns.