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FDA Approves Actemra for Hospitalized Adults with COVID-19

December 28, 2022

The FDA has approved Roche’s Actemra (tocilizumab) for intravenous treatment of hospitalized adults who have COVID-19 and are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.

A single 60-minute intravenous infusion monoclonal antibody treatment, Actemra was granted Emergency Use Authorization (EUA) in June 2021 to treat hospitalized adults and children two years and older who have COVID-19.

The agency approval was based on positive results from two clinical trials, but the EUA is still in place for patients under 18 years old.

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