FDA Approves Roche's Tocilizumab As First Monoclonal Antibody For COVID-19 Treatment

The FDA approved Roche Holdings AG's RHHBY Actemra (tocilizumab) intravenous (IV) for COVID-19 in hospitalized adult patients.
Roche said that the drug was approved for COVID patients receiving certain steroids and who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or life support equipment extracorporeal membrane oxygenation.
Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.
Four studies evaluated Actemra for COVID-19 in more than 5,500 hospitalized patients.
In November, FDA pulled authorization for Eli Lilly And Co's LLY COVID monoclonal antibody treatment, bebtelovimab, saying it was not fighting the dominant BQ.1 and BQ.1.1 subvariants of Omicron as expected.
The FDA approval follows the FDA's Emergency Use Authorization (EUA) for Actemra in hospitalized adults and children with COVID-19, which was granted in June 2021.
More than one million people hospitalized with COVID-19 have been treated with Actemra worldwide since the pandemic's beginning.
Price Action: RHHBY shares are down 0.69% at $39.65 on the last check Thursday.