The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for bebtelovimab, a monoclonal antibody that has been reported to retain activity against the Omicron variant.

Bebtelovimab has been granted EUA for the treatment of mild to moderate COVID-19 in people aged 12 years and above, who have a risk of progression to severe disease. The agency stated that laboratory tests have shown that bebtelovimab retains its activity against both the Omicron variant and the BA.2 Omicron subvariant.

The antibody treatment has not been approved for use in hospitalized patients or those who need oxygen therapy, as it has not been evaluated in this population and could possibly worsen the outcomes. The EUA is supported by results from the phase II BLAZE-4 trial.

The agency stated that COVID-related hospitalizations and deaths were found to be lower among patients who received bebtelovimab alone or in combination with other antibodies compared to those who were given placebo… (Medpage Today)