US FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19
FDA has revised the emergency use authorization for bamlanivimab and etesevimab to include emergency use as post-exposure prophylaxis for COVID-19 in adults & children (≥12 yrs weighing ≥40kg) at high risk of progression to severe COVID-19, including hospitalisation or death.
Source:
US Food and Drug Administration
SPS commentary:
The monoclonal antibodies bamlanivimab and etesevimab, administered together, remain authorized in the US for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients (≥12 years weighing ≥40kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Their use is not yet approved in the EU, although a rolling review of bamlanivimab is underway.
The FDA previously granted emergency authorisation for the use of bamlanivimab alone for the treatment of mild-to-moderate COVID-19 in adults and certain paediatric patients, but this was later revoked, based on ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure.