Date:
October 18, 2021
Issue #:
1635
Summary:
In February 2021, the FDA issued an Emergency Use
Authorization (EUA) for the investigational monoclonal
antibodies bamlanivimab and etesevimab (Lilly) for
use together to treat mild to moderate COVID-19
in persons ≥12 years old who weigh ≥40 kg and
are at high risk of progression to severe disease or
hospitalization. The FDA has now expanded this
EUA to allow use of the antibodies together for post-exposure
prophylaxis of COVID-19 in such persons
if they are not fully vaccinated against COVID-19 or
are unlikely to have an adequate immune response
to full vaccination and have been in close contact
with a SARS-CoV-2-infected individual or are likely
to be exposed to SARS-CoV-2 in the setting of an
institutional outbreak (see Table 1). Bamlanivimab
plus etesevimab is the second monoclonal antibody
combination to receive an EUA for post-exposure
prophylaxis of COVID-19; casirivimab plus imdevimab
(REGEN-COV) was authorized earlier.
Authorization (EUA) for the investigational monoclonal
antibodies bamlanivimab and etesevimab (Lilly) for
use together to treat mild to moderate COVID-19
in persons ≥12 years old who weigh ≥40 kg and
are at high risk of progression to severe disease or
hospitalization. The FDA has now expanded this
EUA to allow use of the antibodies together for post-exposure
prophylaxis of COVID-19 in such persons
if they are not fully vaccinated against COVID-19 or
are unlikely to have an adequate immune response
to full vaccination and have been in close contact
with a SARS-CoV-2-infected individual or are likely
to be exposed to SARS-CoV-2 in the setting of an
institutional outbreak (see Table 1). Bamlanivimab
plus etesevimab is the second monoclonal antibody
combination to receive an EUA for post-exposure
prophylaxis of COVID-19; casirivimab plus imdevimab
(REGEN-COV) was authorized earlier.
