Infectious Disease

The FDA points an EUA for monoclonal antibodies to deal with COVID-19

February 10, 2021

1 min read

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The FDA approved the emergency use of the monoclonal antibodies bamlanivimab and eesevimab together for the treatment of patients with mild to moderate COVID-19.

The treatment is approved for use in patients 12 years of age and older who weigh at least 88 pounds.

“Today’s move, which is another treatment for COVID-19, reflects the FDA’s strong commitment to working with sponsors to expand potential treatment options that healthcare providers can use to combat this pandemic.” Patrizia Weather in Cavazzoni, MD, A press release states the acting director of the FDA’s Center for Drug Evaluation and Research.

“The data in support of this emergency clearance adds to new evidence suggesting the clinical benefit of neutralizing antibodies for the treatment of COVID-19 in certain patients,” said Cavazzoni. “As part of our program to accelerate coronavirus treatment, the FDA is using all resources at our disposal to provide treatments such as these monoclonal antibodies and further study their safety and effectiveness.”

The Infectious Diseases Society of America does not recommend routine use of bamlanivimab, which received an EUA for patients 12 years and older in November, but has no specific recommendation for etesevimab.

A placebo-controlled study showed that intravenous infusion of bamlanivimab and eesevimab significantly reduced hospitalization and death-related COVID-19 after 29 days in patients with COVID-19 who were at high risk of disease progression, so the FDA.

The treatment has not been studied in hospitalized patients with COVID-19 and is not approved for this use or for use in patients requiring oxygen therapy due to COVID-19, according to the FDA.

Monoclonal antibodies can be linked to poorer clinical outcomes when given to hospitalized patients with COVID-19 who require mechanical ventilation or who require high oxygen flow.

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