FDA Authorizes Bamlanivimab and Etesavimab for COVID-19
The EUA follows the authorization for lone therapy bamlanivimab for adults and children at risk of severe COVID-19.
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for combination bamlanivimab and etesavimab for the treatment of mild to moderate coronavirus 2019 (COVID-19) in adults and children aged 12 years and older (weighing at least 40 kg).
The authorization for the pair of monoclonal antibodies is indicated for patients who tested positive for SARS-CoV-2 and who are at high risk of progression to severe COVID-19—including persons aged 65 years and older who have certain chronic medical conditions.
Granted to Eli Lilly, the EUA was based on evidence from a clinical trial showing single infusion of intravenous (IV) bamlanivimab and etesevimab administered together significantly reduced hospitalization and death related to COVID-19 during 29 days of follow-up versus placebo.
The randomized, double-blind, placebo-controlled clinical trial included 1035 non-hospitalized adults with mild to moderate COVID-19 symptoms at high risk of progressing to severe disease. Investigators administered single-infusion bamlanivimab 2800 mg and etesevimab 2800 mg together to 518 patients, and placebo to 517 patients.
Hospitalization or death occurred in 36 (7%) patients administered placebo, versus 11 (2%) of patients treated with combined monoclonal antibodies, indicating a 70% reduced risk over 29 days. All 10 deaths (2%) occurred in the placebo group.
Investigators are continuing to assess the safety and efficacy of the investigational combination therapy in COVID-19.
Bamlanivimab was previously granted an EUA by the FDA as a lone 700 mg therapy for the treatment of mild-to-moderate COVID-19 in the same patient population on November 9, 2020. The addition of a combined monoclonal therapy regimen for COVID-19 reflects continued efforts to combat the worst outcomes of the pandemic virus, at a time when more transmissible forms of SARS-CoV-2 are spreading globally.
“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,” Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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 new therapy regimen is not authorized for patients already hospitalized or who require oxygen therapy due to COVID-19.