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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.

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