Health Authority Information
U.S. Food and Drug Administration (FDA)
- The U.S. Food and Drug Administration has not recommended the off-label use of ACTEMRA for COVID-19.
- The FDA has approved initiation of a phase III
clinical trial investigating the use of ACTEMRA in hospitalized
adult patients for severe pneumonia resulting from COVID-19.
Click here to access the FDA
Coronavirus Disease 2019 (COVID-19) page
The Centers for Disease Control and Prevention (CDC)
In the current Interim Clinical Guidance for Management of Patients with Confirmed COVID-19 by the CDC, the following is stated:
- “No specific treatment for COVID-19 is currently FDA-approved…Inpatient management revolves around the supportive management of the most common complications of severe COVID-19…”
- At present, ACTEMRA is not mentioned for
management of COVID-19.
United States Department of Health and Human Services (HHS)
- The U.S. Department of
Health and Human Services has not recommended the off-label use of
ACTEMRA in COVID-19 patients.
Click here to view HHS
Coronavirus (COVID-19) Updates
The World Health Organization (WHO)
- In an interim guidance published on May 27, 2020, the WHO has recommended that Actemra not be administered as treatment or prophylaxis for COVID-19 outside of the context of clinical trials. The full interim guidance document can be accessed here
- An expert panel was convened to discuss the potential role of IL-6 inhibition in the clinical management of COVID-19 infection. In an update, the panel discussed several anecdotal reports from single-center observational studies, concluding that “[Further] clinical trials are needed to determine the role of IL-6 blockers in COVID-19, especially the dose and timing of administration (early or late in disease course).” The full report can be accessed here
Click here to access the WHO Coronavirus disease (COVID-19) Pandemic