Anvisa revokes drug authorization against Covid

The Collegiate Board of Anvisa revoked the authorization for emergency use of the association of monoclonal antibodies banlanivimab and etesevimab against Covid-19. The decision took place this Friday (4).

The regulatory agency asked the company to present drug efficacy data against the omicron variant that would subsidize the maintenance of the drug’s emergency use authorization for the treatment of Covid-19.

This is because the ômicron is already predominant in the country, accounting for 96.16% of the sequenced samples, according to Our World in Data.

“In response, the company requested the revocation of the temporary authorization for emergency use and did not present the efficacy data against the ômicron variant”, said Anvisa.

The regulatory agency clarified that it is only authorized to use the remaining stocks of clinical research or imported before this revocation, exclusively for patients with Covid-19.

On January 24 this year, the FDA (Food and Drug Administration), the American regulatory agency, suspended the use of these drugs nationwide. According to the agency, these monoclonal antibodies are not effective against the omicron, the main variant circulating in the US.

The treatment had been approved by Anvisa in May last year. It was indicated for adult and adolescent patients aged 12 and over and who have a confirmed diagnosis of Covid in mild or moderate cases. These patients, however, should be at high risk of developing severe disease.

The drug, developed by the company Eli Lilly, was not indicated for patients already hospitalized and in serious condition. Nor could it be used on those who need oxygen.

Present in the drug, banlanivimab and etesevimab are monoclonal antibodies, artificially produced from clones of a single cell (hence the term “monoclonal”, or “a clone”). These antibodies connect to a single region of molecules foreign to the body and then neutralize it.