FDA Authorizes New Monoclonal Antibody Against Omicron Variant



Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody, bebtelovimab developed by Eli Lily for the treatment of COVID-19 that retains activity against the omicron variant. Bebtelovimab can be used for the treatment of mild to moderate COVID-19 in adults and pediatric patients of 12 years of age and older, weighing at least 40 kilograms, which is about 88 pounds with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19.


Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death. Laboratory testing showed that bebtelovimab retains activity against both the omicron variant and the BA.2 omicron subvariant.


Bebtelovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.


Bebtelovimab is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. It is strongly recommended to get vaccinated and receive a booster if eligible.


Source: Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | FDA


To read about The Reason Behind the Milder Severity of Omicron, Click Here

 

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