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FDA approved the usage of a combination of two monoclonal antibodies (tixagevimab and cilgavimab) for decreasing the risk of getting coronavirus disease in certain people.
The Food and Drug Administration (FDA) has published an emergency use authorization (EUA) for tixagevimab co-packaged with cilgavimab and given together (Evusheld) for the pre-exposure prevention of coronavirus disease in specific adults and pediatrics (twelve years of age and older weighing at least forty kilograms [about eighty-eight pounds]), according to the notification published on 8 December 2021.
These long-acting monoclonal antibodies are particularly directed against spike protein of coronavirus. They are designed for blocking the attachment and entrance of virus into human cells. They bind to distinct, non-overlapping sites on spike protein of SARS-CoV-2. Evusheld is only authorized for those people who have not recently been exposed to a coronavirus-infected person and for those people who are not coronavirus-positive. The approval also needs that people either have:
For pre-exposure prophylaxis for about 6 months, Evusheld's single dose, given as 2 separate consecutive intramuscular injections (1 injection per monoclonal antibody, given in immediate succession), might be efficacious. It is not approved for people to treat coronavirus disease or for the post-exposure prevention of coronavirus disease. People must discuss with their medical care providers to find out if Evusheld is a suitable pre-exposure prevention choice for them.
In people for whom coronavirus vaccination is suggested, pre-exposure prophylaxis with tixagevimab and cilgavimab is not an alternative option for vaccination. The EUA was granted based on the findings from a randomized, placebo-controlled, double-blind, clinical trial (PROVENT) in adults greater than age fifty-nine or with a prespecified chronic medical condition or at an elevated risk of coronavirus infection for other reasons who had not been given coronavirus vaccine and didn't have a history of coronavirus infection or test positive for coronavirus infection at the commencement of the trial.
The primary endpoint ascertained was whether the participant experienced the first case of coronavirus infection after getting Evusheld (3,441 participants received Evusheld) or placebo (1,731 participants received placebo) and before day 183 of the study. In the primary assessment, Evusheld recipients experienced a 77% minimized risk of developing SARS-CoV-2 in comparison with placebo recipients, a statistically significant difference.
In additional assessment, the decrease in the risk of developing SARS-CoV-2 was maintained for Evusheld recipients through 6 months. Headache, cough, fatigue, bleeding at the injection site, and hypersensitivity reactions (including anaphylaxis) are the possible adverse effects of Evusheld. Serious cardiac adverse events were infrequent.
US-FDA
Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals
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