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COVID-19: FDA Approves Actemra for Adults, CDC Reports XBB.1.5 Surge

On Dec. 21, the Food and Drug Administration (FDA) approved the use of Actemra, a monoclonal antibody medication, as a treatment for certain adult patients hospitalized due to COVID-19. The medication is approved for patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

The medication has been found to reduce the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalized. Actemra is given by intravenous infusion and is usually used to treat inflammatory diseases like rheumatoid arthritis.

The FDA first authorized the emergency use of Actemra for adults and children older than 2 years old on June 24, 2021. The medication remains authorized for emergency use in children between the ages of 2 and 18 who are receiving certain steroids and required supplemental oxygen.

CDC Data Indicate Spike In New Omicron Subvariant

Centers for Disease Control and Prevention (CDC) data indicate the emergence of a new subvariant of the SARS-CoV-2 virus that causes COVID-19. The XBB.1.5 omicron subvariant currently accounts for 40 percent of COVID-19 cases in the nation.

COVID-19 cases caused by the XBB.1.5 subvariant have nearly doubled in cases each week for the last four weeks, and the numbers continue to grow.

To slow further spread of COVID-19 in the United States, the CDC again will require a negative COVID-19 test or documentation of recovery for air passengers boarding flights to the United States originating from China, starting Jan. 5.

A recent surge in COVID-19 cases in China has left global health agencies on high alert, citing a lack of adequate and transparent epidemiological and viral genomic sequence data reported by China.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Andrea Lugo is a communications associate at America's Essential Hospitals.

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