The Collegiate Board of Anvisa revoked, this Friday (2), the authorization it had granted to the emergency use of an antibody cocktail (banlanivimab and etesevimab) for the treatment of Covid-19, from the company Eli Lilly.
The cocktail had received authorization from Anvisa for emergency use on May 13, 2021.
According to the agency, the authorization was suspended after the company was asked to present data on the effectiveness of the drugs against the Ômicron variant. However, the laboratory did not present them and requested the revocation of the authorization.
At the moment, the use of remaining stocks of antibodies for clinical research or that were important before the revocation is still authorized “exclusively for patients contaminated with variants of Sars-CoV-2 known to be susceptible to these drugs and under medical evaluation”.
It is important to note that, according to the Our World In Data platform, the Ômicron variant is already responsible for 96.46% of the samples of the new coronavirus sequenced in Brazil.
In this context, vaccines are still the most important weapon, as Meiruze Freitas, reporting director for Anvisa, highlights: “To date, even in the context of the circulation of the Ômicron variant, vaccines continue to offer considerable protection against deaths, hospitalization and the development of of Covid-19 in severe forms, especially after a booster dose.”
What was the approved treatment like?
Anvisa’s indication – now revoked – was for the treatment of Covid-19, in mild and moderate forms, in adults and children aged 12 years or older and weighing at least 40 kilos. These patients should still be at high risk of disease progression to the severe form or that could lead to the need for hospitalization.
Both banlanivimab and etesevimab are human immunoglobulin G-1 monoclonal antibodies (known as IgG1) and were developed by a Chinese hamster and ovarian cell line to neutralize the Sars-CoV-2 spike protein.
The mechanism of action of these antibodies blocks the binding of this protein to human angiotensin-converting enzyme 2 (ACE2) receptors, thus preventing the subsequent entry of the virus into human cells and its replication.
Source: CNN Brasil
