Monoclonal drug wins approval after FDA revoked Eli Lilly's COVID-19 drug 

The FDA approved Roche's monoclonal antibody to treat COVID-19 Dec. 21, about three weeks after the agency reversed its authorization for Eli Lilly's monoclonal drug. 

Roche's drug, Actemra (tocilizumab) intravenous, is intended for a single, 1-hour infusion. The FDA approved it for the treatment of hospitalized COVID-19 adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation, according to a Roche news release. 

Eli Lilly's bebtelovimab had emergency use authorization for about nine months until Nov. 30, when the FDA revoked the EUA because omicron subvariants BQ.1 and BQ.1.1 "showed a large reduction in susceptibility," or a 672-fold drop, ​​to the monoclonal antibody.

Before becoming the first FDA-approved monoclonal antibody to treat COVID-19, Actemra received emergency use authorization in June 2021. 


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