FDA issued an emergency use authorization (EUA) for AstraZeneca’s (NSDQ:AZN) Evusheld antibody cocktail as pre-exposure prophylaxis for COVID-19. The indications for use limit its use to adults and children at least 12 years old who weigh at least 40 kg.
The EUA covers individuals who are not sick with COVID-19 who have not been exposed to individuals who have contracted the respiratory illness.
The EUA requires recipients to be at least moderately immunocompromised or to have had a history of severe adverse reactions to a COVID-19 vaccine.
AstraZeneca announced in October that it had filed for the EUA, including data form the PROVENT and STORM CHASER Phase 3 trials.
“Vaccines have proven to be the best defense available against COVID-19. 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,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
Evusheld includes the antibodies tixagevimab and cilgavimab.
AstraZeneca has inked a deal with the U.S. government to provide 700,000 doses of the drug.
Vanderbilt University initially discovered the drug, which is available as two intramuscular injections administered sequentially.
One treatment provides up to one year of protection. Compared to placebo, Evusheld provided 77% protection in the PROVENT trial against symptomatic COVID disease.
Filed Under: clinical trials, Drug Discovery