USFDA revokes emergency use status to two Covid antibody therapies

The USFDA has revised the authorizations for two monoclonal antibody treatments bamlanivimab and etesevimab sold by Eli Lilly and Regeneron’s casirivimab and imdevimab – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.

“Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, t ..
According to the data of the US Centers for Disease Control and Prevention, the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the US as of January 15.

The USFDA revision of approval was based on the National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel, an independent panel of national experts, recently recommended against the use of the two monoclonal antibodies because of markedly reduced activity against the omicron variant and  ..