FDA Authorizes Fourth Monoclonal Antibody Drug

February 15, 2022

Last Friday, the FDA authorized emergency use of Eli Lilly’s monoclonal antibody treatment, bebtelovimab, for treating mild-to-moderate COVID-19. Bebtelovimab has been shown to be highly effective against the Omicron variant, and is the fourth treatment made available for high-risk COVID patients. It has not been proven whether bebtelovimab can prevent severe disease, but trial data suggest that bebtelovimab may reduce viral replication when taken within 7 days upon onset of COVID-19 symptoms.

Bebtelovimab is authorized for patients who are vulnerable to severe disease due to age and comorbidities, and is available for those 12+ years of age. Bebtelovimab should not be used when other COVID-19 treatment options are available or clinically appropriate. Bebtelovimab is not authorized for those who are already hospitalized for COVID-19 or require oxygen therapy/respiratory support due to COVID-19 or comorbidity.

Side effects may occur, as well as “clinical worsening of COVID-19” after the administration of bebtelovimab, although “it is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19.”

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