Benzinga | Dec 9, 2021 09:47PM EST

AstraZeneca's COVID-19 Therapy Wins FDA Approval As First Antibody To Prevent Infection In Immunocompromised

The FDA authorized the use of AstraZeneca Plc's (NASDAQ:AZN)antibody cocktail to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.

* The antibody cocktail, Evusheld (AZD7442), is only authorized for adults and adolescents who are not currently infected with the novel coronavirus and have not recently been exposed to an infected individual.

* Those 12 and older weighing at least 88 pounds will be eligible for Evusheld.

* Related Link: AstraZeneca's COVID-19 Antibody Cuts Risk Of Symptomatic Disease By 77%.

* The therapy comprises two monoclonal antibodies, tixagevimab 150mg and cilgavimab 150 mg.

* The approval marks a significant step for AstraZeneca, whose widely used COVID-19 vaccine is yet to be approved by U.S. authorities.

* AstraZeneca last month had agreed to supply the U.S. government with 700,000 doses of Evusheld.

* AstraZeneca's therapy, given in two sequential intramuscular injections, is designed to last several months to a year.

* Also See: AstraZeneca's COVID-19 Antibody Shows 83% Protection Over Six Months.

* However, the FDA added that pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 immunization is recommended.

* Price Action: AZN shares are up 0.20% at $55.24 during the premarket session on the last check Thursday.

* Photo by Thomas Breher from Pixabay