FDA Issues EUA for Monoclonal Antibody “Cocktail” for Treatment of COVID-19

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The US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Eli Lilly and Company for bamlanivimab 700 mg and etesevimab 1400 mg administered together for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients.

“Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that bamlanivimab and etesevimab administered together may be effective in treating certain patients with mild or moderate COVID-19,” stated the agency in the February 9, 2021 press release. “When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks.”

Bamlanivimab and etesevimab are authorized to be administered together for the treatment of mild-to-moderate COVID-19 in adults and pediatrics patients (aged ≥12 years weighing at least 88 lbs.) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19.

The authorization also includes treatment for patients aged ≥65 years or who have certain chronic medical conditions.

The EUA was issued based on results from the phase 3 BLAZE-1 clinical trial of patients with COVID-19 at high risk for disease progression, which showed a single intravenous infusion bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and mortality during 29 days of follow-up vs placebo.

The study included 1035 non-hospitalized adults with mild-to-moderate COVID-19 symptoms who were at high risk for severe disease progression. Patients were randomized to receive either a single infusion of bamlanivimab 2800 mg and etesevimab 2800 mg together (n=518) or placebo (n=517).

Hospitalization or mortality occurred in 36 (7%) patients who received placebo vs 11 (2%) patients who received bamlanivimab and etesevimab, a 70% risk reduction (P=0.0004). Also, there were 10 deaths which occurred only in the placebo group.

The safety and effectiveness of bamlanivimab and etesevimab for use in the treatment of COVID-19 are still being evaluated. Bamlanivimab and etesevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

Monoclonal antibodies (such as bamlanivimab and etesevimab) may be associated with worse clinical outcomes when administered to patients hospitalized with COVID-19 who require high flow oxygen or mechanical ventilation, noted the agency in the 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,” said Patrizia Cavazzoni, MD, acting director, Center for Drug Evaluation and Research, FDA, in the same press release.

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