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

• The FDA approved Roche Holdings AG's (OTC: 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 (NYSE: 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.

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