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U.S. health regulators on Friday authorized a new antibody drug that targets the omicron variant, a key step in restocking the nation's arsenal against the latest version of COVID-19.
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]
Sotrovimab, sold under the brand name Xevudy, is a human neutralizing monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2, known as SARS-CoV-2. [ 10 ] [ 12 ] [ 13 ] It was developed by GlaxoSmithKline and Vir Biotechnology, Inc. [ 12 ] [ 14 ] Sotrovimab is designed to attach to the spike protein of SARS-CoV-2.
It consists of two human monoclonal antibodies, casirivimab and imdevimab that must be mixed together and administered as an infusion or subcutaneous injection. [13] [8] [10] The combination of two antibodies is intended to prevent mutational escape. [14] It is also available as a co-formulated product. [13]
As the omicron variant completes its sweep across the U.S., states with scarce supplies of monoclonal antibody therapies continue to use two treatments that federal health officials warn no longer ...
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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use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, [9] [10] [11] and the EUA was revoked in April 2021.
Millions of Americans are eligible to get the treatment, but not enough know they qualify — and not all three options appear to work on omicron cases. COVID Monoclonal Antibody Therapy ...