Therapy Areas: Autoimmune
The FDA authorises the emergency use of Actemra for the treatment of certain hospitalized patients with COVID-19
25 June 2021 -

Public health agency The US Food and Drug Administration on Thursday issued an emergency use authorization (EUA) to Genentech's Actemra for the treatment of with COVID-19 hospitalized adults and paediatric patients receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Actemra (tocilizumab) 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. It is a prescription medication given by intravenous infusion that is US FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis.

In clinical trials of hospitalized patients with COVID-19, Actemra, along routine care patients and 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 decreased, added the agency.

The data supporting this FDA's EUA for Actemra are based on four clinical trials including one randomized, controlled, open-label, platform trial (RECOVERY)] and three randomized, double-blind, placebo-controlled trials (EMPACTA, COVACTA and REMDACTA).

While all four clinical trials contribute to the FDA's understanding of Actemra for the treatment of COVID-19, the most important scientific evidence on the potential benefit of Actemra for its authorized use came from the RECOVERY and EMPACTA trials, concluded the agency.



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