FDA Recommends Emergency Use of Bamlanivimab for COVID-19

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bamlanivimab for the treatment of nonhospitalized patients with mild to moderate COVID-19 who are at high risk for hospitalization and/or progression to severe COVID-19. The issuance of an EUA does not indicate FDA approval.

Bamlanivimab (LY-CoV555) is a monoclonal antibody that targets the receptor-binding domain of the spike protein of SARS-CoV-2. This targeted action may block COVID-19 entry into host cells.

The COVID-19 Treatment Guidelines Panel, part of the National Institute of Health, have determined that there is currently insufficient data to recommend for or against the use of bamlanivimab in COVID-19 treatment.

FDA issuance of the EUA was based on results from the BLAZE-1 study, a phase 2, randomized, placebo-controlled trial that demonstrated potential clinical benefit of bamlanivimab. The study was conducted at 41 US centers and composed 452 patients.

Patients who received bamlanivimab had a significantly greater mean decrease in nasopharyngeal SARS-CoV-2 level from baseline to day 11 compared with patients who received placebo. Additionally, COVID-19-related hospitalization, emergency department visits, and death were lower in patients who received bamlanivimab than those who received placebo over the 28-day treatment period.

Patients at risk of progressing to severe COVID-19 (those who were 65 years of age or older or had a body mass index of 35 m/kg2 or greater) who received bamlanivimab were less likely to be hospitalized (4.2%) than patients in the placebo group (14.6%). More data are needed to fully assess the use of bamlanivimab in the clinical course of COVID-19.

Among the 850 participants who have received bamlanivimab in the ongoing trials, only one anaphylaxis reaction and 1 serious infusion-related reaction have occurred. Both events resolved when infusion and treatment were discontinued.

—Audrey Amos

Reference:

The COVID-19 treatment guidelines panel’s statement on the emergency use authorization of bamlanivimab for the treatment of COVID-19. National Institutes of Health. Updated November 18. 2020. Accessed December 1, 2020.   https://www.covid19treatmentguidelines.nih.gov/statement-on-bamlanivimab-eua.