The U.S. Food and Drug Administration issued an emergency use authorization for the drug Actemra for the treatment of hospitalized COVID- 19 adults and pediatric patients.
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The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Actemra is not authorized for use in outpatients with COVID-19.
In clinical trials of hospitalized patients with COVID-19, Actemra in addition to the routine care patients receive for treatment of COVID-19, which included corticosteroid therapy, was shown to reduce the risk of death through 28 days of follow-up and decrease 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. In the case of COVID-19 infection, the immune system can become hyperactive, which may result in worsening of disease. Actemra does not directly target SARS-COV-2.
Actemra is a prescription medication given by intravenous infusion that is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis. Under today’s EUA, the FDA is authorizing the emergency use of Actemra for the treatment of certain hospitalized patients with COVID-19. Actemra is not approved as a treatment for COVID-19.
Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that Actemra 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 median time to hospital discharge was 19 days for patients receiving Actemra and more than 28 days for patients receiving usual care alone. ■