Anvisa revokes authorization for treatment with monoclonal antibodies against covid - ISTOÉ DINHEIRO

The National Health Surveillance Agency (Anvisa) revoked the authorization for emergency use of the association of monoclonal antibodies banlanivimab and etesevimab for the treatment of covid-19, from the company Eli Lilly, on Friday, 4th. data that prove the effectiveness of the drug against the Ômicron variant – which represents almost 96% of infections in the country.

“Only the use of the remaining stocks of clinical research or imported before this revocation is authorized, exclusively for patients contaminated with variants of Sars-CoV-2 known to be susceptible to these drugs and under medical evaluation”, highlighted the agency, in a note.

The treatment was authorized for emergency use on May 13, 2021. The indication was for use in people with mild to moderate conditions, aged 12 years or older and weighing at least 40 kilograms. The patient should still have a high risk of disease progression to the severe form or that could lead to the need for hospitalization. Administration should only be done in a hospital setting by intravenous infusion.

At the end of January, the Food and Drug Administration (FDA), an American agency equivalent to Anvisa, suspended the use of Eli Lilly’s treatment and that of the company Regeneron (casirivimab and imdevimab) in the United States, as data “strongly” indicate ineffectiveness. of drugs against the strain detected for the first time in South Africa.

Both drugs had been approved for emergency use in Brazil. At the time, Anvisa told the Estadão which notified the companies Eli Lilly and Roche (responsible for marketing the Regeneron drug) to present justification for maintaining the release.

As informed by Anvisa, in response to the request, Eli Lilly requested the revocation of the temporary authorization and did not present the efficacy data against Ômicron.

Monoclonal antibodies are lab-made proteins that mimic the immune system’s ability to fight harmful pathogens, such as the coronavirus, for example. Like any infectious organism, the virus that causes Covid mutates, which can undermine the effectiveness of a given treatment.