The U.S. has approved the use of an “antibody cocktail” from COVID-19
The U.S. has approved the use of an "antibody cocktail" from COVID-19
The U.S. Food and Drug Administration on Wednesday cleared the use of an “antibody cocktail” developed by the British-Swedish company AstraZeneca to prevent COVID-19.
The FDA today issued fast-track approval for Evusheld, also known as AstraZeneca’s AZD7442, for the prevention of COVID-19 in certain adults and children 12 years of age and older who weigh at least 40 pounds in an emergency pandemic situation. The drug is only approved for individuals who are not currently infected with SARS-CoV-2 and have not had recent contact with infected individuals.
Evusheld will only be available to people with compromised immune systems or intolerance to components of the new coronavirus vaccines used in the United States. “Pre-exposure prophylaxis with Evusheld does not constitute a replacement for vaccination for individuals for whom COVID-19 vaccination is recommended,” the FDA stressed.
Evusheld is made from a mixture of two monoclonal antibodies, tixagevimab and zilgavimab. On Oct. 11, AstraZeneca reported that its “antibody cocktail” achieved its goal of preventing severe disease resulting from infection with the SARS-CoV-2 coronavirus. The AZD7442 drug trials primarily enrolled patients at high risk of developing severe COVID-19, including those with comorbidities.