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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]
When used as drugs, the International Nonproprietary Names (INNs) end in -mab. The remaining syllables of the INNs, as well as the column Source, are explained in Nomenclature of monoclonal antibodies. Types of monoclonal antibodies with other structures than naturally occurring antibodies. The abbreviations in the column Type are as follows:
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use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, [9] [10] [11] and the EUA was revoked in April 2021.
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.
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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]
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.