COVID-19 Update:

In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and 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, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.  

Importantly, there are several other therapies nirmatrelvir + ritonavir, sotrovimab, remdesivir and molnupiravir – that are expected to work against the omicron variant, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.

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