Evusheld: Anvisa suspends endorsement of Covid medicine – 03/07/2023 – Health

Anvisa (National Health Surveillance Agency) temporarily suspended, this Tuesday (7), the authorization for the emergency use of the drug Evusheld (or AZD7442), by AstraZeneca, for the treatment of Covid-19.

The authorization is suspended until data are presented that prove the effectiveness of the medicine against the variants of Covid concern in circulation in Brazil.

According to the regulatory agency, the omicron variant and its subvariants are predominant in Brazil, with a recent prevalence of 77% for BQ.1 and 15% for BA.5.

“Anvisa has been monitoring the effectiveness of drugs approved against the new variants of Sars-CoV-2 and, according to the data presented by the company, the drug Evusheld has shown a significant drop in activity against the variants of concern of the new coronavirus in circulation in the country,” he said in a note.

If there are batches of the medicine in Brazilian territory, Anvisa’s recommendation is that the company holding the authorization duly notify health professionals about the ineffectiveness of the medicine against the variants in circulation.

The collegiate board of Anvisa approved in December last year the emergency use of the medicine Evusheld.

The drug is a combination of monoclonal antibodies cilgavimab + tixagevimab. Until then, it was indicated for pre-exposure prophylaxis, that is, for individuals who are not infected with Covid-19 and have not had contact with the virus.

The medicine is also indicated for people who should not take the Covid-19 vaccine due to a history of serious adverse reaction. For those who can use the immunizer, it must be administered at least two weeks after vaccination.

The drug has already been approved by other regulatory agencies in countries such as the United States, France, Israel, Italy, Bahrain, Egypt and the United Arab Emirates.