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Combination Monoclonal Antibody Treatment Authorized for COVID-19

WEDNESDAY, Feb. 10, 2021 -- The combination treatment of bamlanivimab and etesevimab received emergency use authorization (EUA) for mild-to-moderate COVID-19, the U.S. Food and Drug Administration announced Tuesday.

The EUA is indicated for patients 12 years and older (weighing at least 88 lb) who have an increased risk for progressing to severe COVID-19, including patients 65 years and older with chronic medical conditions. The decision follows an EUA issued Nov. 9 for a single infusion of 700 mg bamlanivimab for mild-to-moderate COVID-19 in adults and certain pediatric populations. In a statement, the FDA said both bamlanivimab alone and in combination with etesevimab are expected to benefit patients at high risk for COVID-19 progression, but bamlanivimab and etesevimab combined "resulted in a lower risk of resistant viruses developing during treatment."

Data supporting the EUA are from a randomized, double-blind, placebo-controlled clinical trial of 1,035 patients with mild-to-moderate COVID-19 at high risk for disease progression. Patients were randomly assigned to a single infusion of 2,800 mg bamlanivimab and 2,800 mg etesevimab (518 patients) or placebo (517 patients). At 29 days of follow-up, hospitalization or death occurred in 7 and 2 percent of patients who received placebo and bamlanivimab and etesevimab, respectively. All deaths occurred among patients who received placebo.

The FDA authorized a dosage of 700 mg bamlanivimab and 1,400 mg etesevimab based on preclinical, clinical, and virologic data showing this dosage has similar clinical and virologic effect to the dosage of 2,800 mg bamlanivimab and 2,800 mg etesevimab used in the study.

The combination treatment is not authorized for patients hospitalized or requiring oxygen therapy due to COVID-19, and the FDA notes that use of monoclonal antibodies may be associated with worse clinical outcomes for these patients. Possible side effects of bamlanivimab and etesevimab include nausea, dizziness, pruritis, and rash. Serious adverse events have been reported with bamlanivimab, including hypersensitivity, anaphylaxis, and infusion-related reactions.

"The data supporting this emergency use authorization add to emerging evidence that points to the clinical utility of neutralizing antibodies for the treatment of COVID-19 in certain patients," Patrizia Cavazzoni, M.D., acting director of the FDA Center for Drug Evaluation and Research, said in a statement.

The EUA was issued to Eli Lilly and Co.

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