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On 16 April 2021, the FDA revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. [13] The EUA was issued to Eli Lilly and Co. [3]
Bamlanivimab is a monoclonal antibody developed by AbCellera Biologics and Eli Lilly as a treatment for COVID-19. [8] The medication was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, [9] [10] [11] and the EUA was revoked in April 2021.
On 16 April 2021, the FDA revoked the emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. [69]
The British drugmaker said its new antibody therapy reduced the risk of people developing any COVID-19 symptoms by 77% in a late-stage trial. ... Trial data from AstraZeneca on Friday raised the ...
"I don't think treatment is where we are going to be competing," Mene Pangalos, executive vice president for bio-pharmaceuticals R&D at AstraZeneca, said during a media briefing. Pangalos added ...
In the European Union, the combination is indicated for the treatment of COVID‑19 in people aged twelve years of age and older weighing at least 40 kilograms (88 lb) who do not require supplemental oxygen and who are at high increased risk of progressing to severe COVID‑19; [10] and for the prevention of COVID‑19 in people aged twelve years of age and older weighing at least 40 kilograms ...
Over 2021–22, two Cochrane reviews found insufficient evidence for using neutralizing monoclonal antibodies to treat COVID-19 infections. [53] [54] The reviews applied only to people who were unvaccinated against COVID‐19, and only to the COVID-19 variants existing during the studies, not to newer variants, such as Omicron. [54]
In May 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for sotrovimab for the treatment of mild-to-moderate COVID-19 in people aged twelve years and above weighing at least 40 kilograms (88 lb) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to ...