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.