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The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the arthritis drug tocilizumab (Actemra) for adults and children aged 2 years and older who are hospitalized with severe COVID-19 and are being treated with systemic corticosteroids and supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
The drug is not authorized for use in outpatients with COVID-19.
In clinical trials of patients hospitalized with COVID-19, treatment with tocilizumab plus standard care cut the risk for death, shortened the amount of time patients remained hospitalized, and reduced the need for mechanical ventilation.
“Today’s action demonstrates the FDA’s commitment to making new therapies available through every stage of the global COVID-19 pandemic,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in a news release.
“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,” said Cavazzoni.
It’s now well known that patients with COVID-19 may develop a hyperactive immune system, which may result in worsening of disease. Tocilizumab is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor.
Tocilizumab is given by intravenous infusion and is approved in the United States for multiple inflammatory diseases, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
The FDA says that on the basis of available scientific evidence, it’s “reasonable to believe” that tocilizumab may be effective in the treatment of COVID-19 for the authorized population and that the “known and potential benefits” of the drug outweigh the known and potential risks associated with the drug.
A fact sheet for healthcare professionals that provides additional information about the EUA for tocilizumab for severe COVID-19, including dosing instructions, potential side effects, and drug interactions, is available online.
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