FDA Grants Emergency Use of AstraZeneca’s COVID-19 Prevention Med

Evusheld is the only monoclonal antibody authorized in the United States for COVID-19 pre-exposure prophylaxis.

FDA has issued an emergency use authorization (EUA) for AstraZeneca’s preventive COVID-19 monoclonal antibody Evusheld (tixagevimab co-packaged with cilgavimab and administered together).

Evusheld, the only antibody authorized in the United States for COVID-19 pre-exposure prophylaxis and the only COVID-19 antibody delivered as an intramuscular dose, will be available soon, AstraZeneca said in a statement.

The treatment is only authorized for adults and children 12 years and older who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2, the FDA said in a statement.

“Vaccines have proven to be the best defense available against COVID-19,” said Patrizia Cavazzoni, M.D., 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.”

One dose of Evusheld, administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), may be effective for pre-exposure prevention for six months, the FDA said.

The medication is needed because around 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine, AstraZeneca said.

In addition, around seven million people in the United States are immunocompromised. “This includes people with blood cancers or other cancers being treated with chemotherapy, and those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis,” AstraZeneca said.

“Millions of people in the United States and around the world remain at serious risk for COVID-19 because their immune systems do not generate a sufficient immune response, even after receiving all recommended doses of vaccine,” said Myron J. Levin, M.D., principal investigator on AstraZeneca’s PROVENT clinical trial and professor of pediatrics and medicine at the University of Colorado School of Medicine.

AstraZeneca is working quickly to establish Evusheld’s efficacy against the SARS-CoV-2 omicron variant, said Mene Pangalos, executive vice president of BioPharmaceuticals R&D for AstraZeneca.

AstraZeneca’s PROVENT randomized, double-blind, placebo-controlled clinical trial studied adults ages 59 and above or with a pre-specified chronic medical condition or at increased risk of SARS-CoV-2 infection for other reasons who had not received a COVID-19 vaccine and did not have a history of SARS-CoV-2 infection or test positive for SARS-CoV-2 infection at the start of the trial.

In the primary analysis, Evusheld recipients saw a 77% reduced risk of developing COVID-19 compared with those who received a placebo. In additional analyses, the reduction in risk of developing COVID-19 was maintained for Evusheld recipients through six months.

The FDA’s EUA for Evusheld requires that individuals either have moderate-to-severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of the vaccines.

AstraZeneca has agreed to supply the U.S. government with 700,000 doses of Evusheld. The U.S. government has indicated that it plans to distribute these doses to states and territories at no cost and on a pro rata basis.