The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bamlanivimab (Eli Lilly and Company) for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
Bamlanivimab is an investigational, intravenously administered monoclonal antibody that is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.
Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of bamlanivimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
The EUA authority allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. Medical countermeasures are medical products such as drugs, vaccines, diagnostic tests, and other medical equipment and supplies needed to respond to emergencies involving such threats. Bamlanivimab has not been granted conventional FDA approval for any indication.
Food and Drug Administration (FDA). Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 [news release]. November 9, 2020. Available at: click here. Accessed November 10, 2020.