AstraZeneca’s long-acting Evusheld antibody ‘cocktail’ gained emergency use authorization for the prevention of Covid-19 among those with compromised immune systems.
First does are expected soon, according to the company. The emergency use OK could help millions of people who cannot get protection from vaccines.
The Food and Drug Administration granted the designation for Evusheld in adults and adolescents (ages 12 and older) who are immune-compromised due to a medical condition or medications and who may not mount an adequate immune response to a Covid-19 vaccination. The drug combo also helps those who are not recommended for a Covid vaccination.
The autorization does not cover those who have the virus.
Myron J. Levin, MD, professor of pediatrics and medicine, University of Colorado School of Medicine, and principal investigator on the ongoing Provent trial, said: “Millions of people in the US 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. I am excited to offer my patients Evusheld as an easily-administered new option that provides long-lasting protection that could help them return to their everyday lives.”
Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorized in the US for Covid-19 pre-exposure and the only Covid-19 antibody delivered as an intramuscular dose.
About 2% of the global population is considered at increased risk of an inadequate response to a Covid-19 vaccine.
About seven million people in the US are immunocompromised and may benefit from Evusheld. 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.
The ongoing Provent Phase III trial, showed a 77% reduction at primary analysis (83% at median six-month analysis) in the risk of developing symptomatic Covid-19 compared to placebo, with protection from the virus continuing for at least six months.
More follow-up will be undertaken for the full duration of protection provided by Evusheld.
AstraZeneca employs 1,500 in Delware in logistics, manufacturing and headquarters positions.
