U.S. FDA Authorizes Drug for Treatment of COVID-19

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on June 24, 2021, 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 a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor.

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 to treat certain hospitalized patients with COVID-19 and 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 number of time patients remained hospitalized.

The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased.

“Today’s action demonstrates the FDA’s commitment to making new therapies available through every stage of the global COVID-19 pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press statement.

“Although vaccines have been successful in decreasing the number of patients with COVID-19 who require hospitalization, providing additional therapies for those who do become hospitalized is an important step in combating this pandemic.”

The EUA was issued to Genentech Inc.