FDA authorizes COVID-19 antibody therapy

Abstract

The US Food and Drug Administration has granted an emergency use authorization (EUA) for Eli Lilly and Company’s experimental monoclonal antibody treatment for COVID-19 . The antibody, called bamlanivimab, neutralizes SARS-CoV-2 by binding to its spike protein and thereby preventing the virus from gaining a foothold into human cells. “This is welcome news and supports growing evidence that potent neutralizing antibodies can benefit those in the early stages of infection,” Scripps Research scientist Dennis Burton says in an email. Bamlanivimab is the first drug discovered during the pandemic to receive an EUA—every other treatment granted the status so far had been studied previously or approved for other diseases. A Phase 2 study in people with mild or moderate COVID-19 found that the antibody reduced the amount of coronavirus detected in a nasopharyngeal swab. In a result that scientists found puzzling, the effect was statistically significant only at the medium dose