FDA issues EUA for monoclonal antibodies to treat COVID-19
The FDA authorized the emergency use of the monoclonal antibodies bamlanivimab and etesevimab together to treat patients with mild to moderate COVID-19.
The treatment is authorized for use in patients aged 12 years or older weighing at least 88 pounds.
“Today’s action, which provides another treatment for COVID-19, reflects the FDA’s strong commitment to working with sponsors to expand potential treatment options health care providers can use to fight this pandemic,” Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, said in a press release.
“The data supporting this emergency authorization add to emerging evidence that points to the clinical utility of neutralizing antibodies for the treatment of COVID-19 in certain patients,” Cavazzoni said. “As part of our Coronavirus Treatment Acceleration Program, the FDA uses every resource at our disposal to make treatments such as these monoclonal antibodies available while continuing to study their safety and effectiveness.”
The Infectious Diseases Society of America recommends against the routine use of bamlanivimab — which received an EUA in November for patients aged 12 years or older — but does not have a specific recommendation for etesevimab.
A placebo-controlled trial showed that one IV infusion of bamlanivimab and etesevimab significantly decreased COVID-19-related hospitalization and death at 29 days of follow-up in patients with COVID-19 who were at high risk for disease progression, the FDA said.
The treatment has not been studied in hospitalized patients with COVID-19 and is not authorized for this use, or for use in patients who require oxygen therapy due to COVID-19, the FDA said.
Monoclonal antibodies may be associated with poorer clinical outcomes if administered to hospitalized patients with COVID-19 who need mechanical ventilation or require high oxygen flow, the agency said.
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