FDA authorizes monoclonal antibodies for treatment of COVID-19

FDA on Tuesday granted emergency use authorization (EUA) to a COVID-19 treatment that combines the monoclonal antibodies bamlanivimab and etesevimab (Eli Lilly). Under the EUA, bamlanivimab and etesevimab are administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients aged 12 years or older weighing at least 40 kg who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. FDA notes the authorized use includes treatment for individuals aged 65 years or older or who have certain chronic medical conditions. A clinical trial of patients with COVID-19 at high risk for disease progression found that a single I.V. infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death over 29 days of followup compared with placebo. Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, said: “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.” The EUA requires that fact sheets that include key information about using bamlanivimab and etesevimab administered together in treating COVID-19 as authorized must be made available to health care providers and to patients and caregivers. These fact sheets include dosing instructions, potential adverse effects, and drug interactions.