FDA Revokes Emergency Use Authorization (EUA) for Bamlanivimab for treatment of mild-to-moderate COVID-19
The EAU was revoked on the basis of ongoing analysis of emerging scientific data, which found a sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab monotherapy resulting in an increased risk of treatment failure and unfavourable risk-benefit.
Source:
FDA
SPS commentary:
The FDA notes that alternative therapies for treatment of mild-to-moderate COVID-19 remain available under an EUA: REGEN-COV (casirivimab and imdevimab), and dual therapy with bamlanivimab and etesevimab.