On November 18, 2020, the National Institutes of Health (NIH) issued a statement on the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) of bamlanivimab for the treatment of COVID-19.

Bamlanivimab (Eli Lilly and Company) is a neutralizing monoclonal antibody that targets the receptor-binding domain of the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On November 10, 2020, the FDA issued an EUA for bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.

The NIH panel has determined that based on the available evidence, at this time, there are insufficient data to recommend either for or against the use of bamlanivimab for the treatment of outpatients with mild to moderate COVID-19. The NIH statement further notes the following:

  • Bamlanivimab should not be considered the standard of care for the treatment of patients with COVID-19.

  • An interim analysis of the BLAZE-1 study, a Phase 2, randomized, placebo-controlled trial, suggested a potential clinical benefit of bamlanivimab for outpatients with mild to moderate COVID-19. However, the relatively small number of participants and the low number of hospitalizations or emergency department visits make it difficult to draw definitive conclusions about the clinical benefit of bamlanivimab.

  • More data are needed to assess the impact of bamlanivimab on the disease course of COVID-19 and to identify those people who are most likely to benefit from the drug. Health care providers are encouraged to discuss participation in bamlanivimab clinical trials with their patients.

  • Given the possibility of a limited supply of bamlanivimab, as well as challenges distributing and administering the drug, patients at highest risk for COVID-19 progression should be prioritized for use of the drug through the EUA. In addition, efforts should be made to ensure that communities most affected by COVID-19 have equitable access to bamlanivimab.

  • Bamlanivimab should not be withheld from a pregnant individual who has a condition that poses a high risk of progression to severe COVID-19, and the clinician thinks that the potential benefit of the drug outweighs potential risk (see the criteria for EUA use of bamlanivimab below).

  • Patients who are hospitalized for COVID-19 should not receive bamlanivimab outside of a clinical trial.

  • The Panel will continue to evaluate emerging clinical data on the use of bamlanivimab for the treatment of outpatients with mild to moderate COVID-19 and anticipates updating these recommendations as more information becomes available.

National Institutes of Health (NIH). The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Bamlanivimab for the Treatment of COVID-19. November 18, 2020. Available at: click here. Accessed November 19, 2020