The U.S. Food and Drug Administration (FDA) approved this week an emergency use authorization (EUA) for AstraZeneca’s Evusheld, authorizing the use of monoclonal antibodies to reduce specific COVID-19 risk.
Evusheld is tixagevimab co-packaged with cilgavimab and administered together to address the prevention of COVID-19 in certain adults and pediatric individuals.
The FDA noted the product would be administered solely to those individuals who are not currently infected with the SARS-CoV-2 virus and have not recently been exposed to an individual infected with SARS-CoV-2.
“Vaccines have proven to be the best defense available against COVID-19,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “However, there are certain immune-compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option.”
Cavazzoni said the FDA’s action authorizes the combination of two monoclonal antibodies to reduce the risk of developing COVID-19 in the targeted individuals.
According to the FDA, a single dose of Evusheld administered as two separate consecutive intramuscular injections may be effective for pre-exposure prevention for six months. Monoclonal antibodies are laboratory-made proteins capable of mimicking the immune system’s ability to fight off pathogens such as viruses.
“We are proud to play a leading role in fighting the COVID-19 pandemic and, with Evusheld, we now have the first antibody therapy authorized in the US to prevent COVID-19 symptoms before virus exposure, while also providing long-lasting protection with a single dose,” Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said. “Evusheld neutralizes all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant.”