FDA suspends use of AstraZeneca treatment for Covid – 01/27/2023 – Health

The FDA, the American drug and food regulatory agency in the United States, suspended last Thursday (26) the authorization for emergency use of AstraZeneca’s Covid treatment, Evusheld.

The agency’s assessment is that the drug has no evidence of neutralization (that is, of preventing cell action) of omicron subvariants, including XBB.1.5, which is currently dominant in the American country.

Earlier this month, the FDA had already issued an alert about the likely loss of effectiveness of the drug against omicron stresses.

Composed of two monoclonal antibodies, cilgavimab and tixagevimab, the treatment was indicated for people at risk of developing severe Covid-19.

In Brazil, Anvisa (National Health Surveillance Agency) approved emergency use in December last year as a treatment for Covid. Until then, it was only authorized for use as pre-exposure prophylaxis, that is, for those who have not yet been infected with the coronavirus but present some risk of exposure.

The report requested information from Anvisa if Evusheld may also have its use suspended in the country, but did not receive a response from the agency until the publication of this text.

Monoclonal antibodies are artificially made based on clones of a single cell that help to neutralize the virus. Its use is contraindicated in patients who require mechanical ventilation or in children under 12 years of age.

As monoclonal antibodies were produced from old variants of the virus, which are no longer in circulation, their effectiveness against new strains tends to drop. In the case of omicron, with the mutations that have been accumulated by the new underlines, the neutralization capacity ends up being directly impacted.

In addition to Evusheld, other drugs with the same principle are Regen-Cov, the first to be authorized in Brazil, Eli Lilly’s cocktail (banlanivimab and etesevimab), regdanvimab, from Celltrion Healthcares, and sotrovimab, from GlaxoSmithKline (GSK).