Anvisa approves first drug to prevent Covid-19

The collegiate board of Anvisa (National Health Surveillance Agency) unanimously approved the emergency use of the drug Evusheld (or AZD7442) from AstraZeneca against Covid-19.

The drug is a combination of monoclonal antibodies cilgavimab + tixagevimab. It should be used as pre-exposure prophylaxis, that is, individuals who are not currently infected with Covid-19 and have not had contact with the virus.

It is indicated for people aged 12 years and older who have moderate to severe immune compromise. People who have received an organ transplant, who have moderate or severe primary immunodeficiency (DiGeorge syndrome), who are undergoing treatment for leukemia, are part of the group. It can also be used for those who have advanced or untreated HIV infection.

It can also be used for whom the Covid-19 vaccine is not recommended due to a history of serious adverse reaction.

However, for whom vaccination is indicated, the drug does not replace it. In this case, the drug must be administered at least two weeks after the application of the immunizer.

“Pre-exposure prophylaxis with Evulsheld is not a substitute for vaccination in individuals for whom Covid-19 vaccination is recommended. We are emphasizing that it is not to replace vaccination,” Mendes said.

Meiruze Sousa Freitas, reporting director of Anvisa, said that in the current scenario of the pandemic, the use of a product for prophylaxis can provide another strategy to protect the population.

“I believe that pre-exposure prophylaxis can be an important weapon to combat the diseases of the most vulnerable who are at risk of being hospitalized and of death, such as people with leukemia, primary or acquired immunodeficiency or those who undergo immunosuppressive treatments, with people transplanted, he pointed out.

However, she warns that treated patients should continue with care measures against Covid, such as wearing a mask, maintaining isolation, not sharing personal items and frequent hand hygiene.

In November, pharmaceutical company AstraZeneca announced that its monoclonal antibody was able to reduce the risk of Covid-19 and also that of developing severe illness and death.

The Ministry of Health has already started conversations with AstraZeneca for the acquisition of medicines against Covid-19.

Anvisa has already approved six other drugs for Covid-19. One of them is Regen-Cov (combination of casirivimab and imdevimab), from pharmaceutical company Regeneron, which has approval for emergency use in Brazil.

Among the approved drugs, the regulatory agency revoked the authorization for emergency use of the association of monoclonal antibodies banlanivimab and etesevimab against Covid-19.

The regulatory agency asked the company to present drug efficacy data against the omicron variant to support the maintenance of the drug’s emergency use authorization for the treatment of Covid-19, which did not happen.