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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use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, [9] [10] [11] and the EUA was revoked in April 2021.
Pemivibart, sold under the brand name Pemgarda, is a monoclonal antibody medication authorized for the pre-exposure prophylaxis (prevention) of COVID‑19. [4] Pemivibart was developed by Invivyd. [3] [5] The US Food and Drug Administration (FDA) issued an emergency use authorization for pemivibart in March 2024. [4] [5]
Monoclonal antibody treatments are lab-based molecules that mimic the body’s immune response to infection. They are most often given through IV infusion, though some can be delivered with an ...
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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]
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A benefit of casirivimab and imdevimab treatment has not been shown in people hospitalized due to COVID‑19. [9] Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized people with COVID‑19 requiring high flow oxygen or mechanical ventilation. [9]