In a press release issued on December 21, 2022, the manufacturer, Genentech, a member of the Roche Group, announced that the FDA approved Actemra (tocilizumab) for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or 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.

Levi Garraway, MD, PhD, CMO and head of Global Product Development, stated, “With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19. Actemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalized patients and their healthcare providers who continue to be on the frontlines treating COVID-19.”

Four randomized, controlled studies assessed Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. Collectively, the results of these four studies (the University of Oxford-led RECOVERY trial, along with the Genentech-sponsored global trials, EMPACTA, COVACTA, and REMDACTA) demonstrated that Actemra may enhance outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.

The FDA approval is based on the results from the RECOVERY trial, as well as the EMPACTA trial, the first global, phase III study in COVID-19 to focus on patients from underrepresented racial and ethnic groups. No new warnings and precautions related to Actemra in COVID-19 studies have been identified. The most common adverse reactions observed (incidence ≥3%) are constipation, urinary tract infection, hypertension, anxiety, diarrhea, insomnia, and nausea.

The FDA approval follows the FDA’s emergency use authorization (EUA) for Actemra in hospitalized adults and children (aged 2 years and older) with COVID-19, which was granted in June 2021. The use of Actemra to treat hospitalized individuals aged 2 years to <18 years is not FDA approved; however, the EUA for this age group currently remains in place after the FDA approval for hospitalized adult patients.

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