The drug is for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
In COVID-19 clinical trials, Actemra was shown to reduce the risk of death through 28 days of follow-up and decreased the amount of time patients remained hospitalized. The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased.
Actemra is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor. It does not directly target SARS-CoV-2, rather it is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis.
Under the EUA, the FDA is authorizing the emergency use of Actemra for the treatment of certain hospitalized patients with COVID-19.
Actemra is not approved for the treatment of COVID-19. However, the agency has determined that it is reasonable to believe that the drug may be effective in treating COVID-19 for the authorized population. And when used to treat COVID-19 for the authorized population, the known and potential benefits of Actemra outweigh the known and potential risks for the drug.
The data to support the EUA are based on four clinical trials, which include one randomized, controlled, open-label, platform trial and three randomized, double-blind, placebo-controlled trials.
The agency's decision was primarily based on data from the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial and the EMPACTA trial.
The RECOVERY trial evaluated the drug among 4,116 hospitalized patients with severe COVID-19 pneumonia who received Actemra in addition to usual treatment or only usual treatment, and the EMPACTA trial evaluated 389 hospitalized patients with COVID-19 pneumonia who received either Actemra or a placebo.
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