Bamlanivimab/etesevimab is a combination of two
monoclonal antibodies
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell.
Monoclonal antibodies ca ...
,
bamlanivimab
Bamlanivimab is a monoclonal antibody developed by AbCellera Biologics and Eli Lilly as a treatment for COVID-19. The medication was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, and ...
and
etesevimab
Bamlanivimab/etesevimab is a combination of two monoclonal antibodies, bamlanivimab and etesevimab, administered together via intravenous infusion as a treatment for COVID-19. Both types of antibody target the surface spike protein of SAR ...
, administered together via intravenous infusion as a treatment for
COVID-19
Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was COVID-19 pandemic in Hubei, identified in Wuhan, China, in December ...
.
[ ] Both types of antibody target the
surface spike protein of
SARS‑CoV‑2.
Bamlanivimab and etesevimab, administered together, are authorized in the United States for the treatment of mild-to-moderate COVID-19 in people aged twelve years of age and older weighing at least 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.
[ ] They are also authorized, when administered together, for use after exposure to the SARS-CoV-2 virus for
post-exposure prophylaxis
Post-exposure prophylaxis, also known as post-exposure prevention (PEP), is any preventive medical treatment started after exposure to a pathogen in order to prevent the infection from occurring.
COVID-19
In 2021, the FDA has approved bamlanivi ...
(PEP) for COVID-19 and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus.
In January 2022, the U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) revised the authorizations for two monoclonal antibody treatments – bamlanivimab/etesevimab (administered together) and
casirivimab/imdevimab
Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others, Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. is a combination medicine ...
– to limit their use to only when the recipients are likely to have been infected with or exposed to a variant that is susceptible to these treatments.
[ ] Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.
Contents
Etesevimab
Etesevimab is a monoclonal antibody against the
surface spike protein of SARS‑CoV‑2.
Eli Lilly licensed etesevimab from Junshi Biosciences.
Bamlanivimab
Bamlanivimab is an IgG1 monoclonal antibody (mAb) directed against the spike protein of
SARS‑CoV‑2. The aim is to block viral attachment and entry into human cells, thus neutralizing the virus, and help preventing and treating COVID-19.
Trials
The data supporting the emergency use authorization (EUA) for bamlanivimab and etesevimab are based on a randomized, double-blind, placebo-controlled clinical trial in 1,035 non-hospitalized participants with mild to moderate COVID-19 symptoms who were at high risk for progressing to severe COVID-19.
Of these participants, 518 received a single infusion of bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams together, and 517 received placebo.
The primary endpoint was COVID-19 related hospitalizations or death by any cause during 29 days of follow-up.
Hospitalization or death occurred in 36 (7%) participants who received placebo compared to 11 (2%) participants treated with bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams administered together, a 70% reduction.
All ten deaths (2%) occurred in the placebo group.
Thus, all-cause death was significantly lower in the bamlanivimab 2,800-milligram and etesevimab 2,800-milligram group than the placebo group.
Economics
On 26 February 2021, the United States government agreed to purchase 100,000 doses of the drug for $210 million, at $2,100 per dose.
Research
COVID-19
In February 2021, the FDA issued an emergency use authorization (EUA) for bamlanivimab and
etesevimab
Bamlanivimab/etesevimab is a combination of two monoclonal antibodies, bamlanivimab and etesevimab, administered together via intravenous infusion as a treatment for COVID-19. Both types of antibody target the surface spike protein of SAR ...
administered together for the treatment of mild to moderate COVID-19 in people twelve years of age or older weighing at least who test positive for SARS‑CoV‑2 and who are at high risk for progressing to severe COVID-19.
The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. While bamlanivimab and etesevimab administered together resulted in a lower risk of resistant viruses developing during treatment compared with bamlanivimab administered alone, both treatments are available under an EUA and are expected to benefit people at high risk of disease progression.
On 16 April 2021, the FDA revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients.
[ ] The EUA was issued to Eli Lilly and Co.
In February 2021, the
Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding ...
(CHMP) of the
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
(EMA) started rolling reviews of data on the use of the monoclonal antibodies
casirivimab/imdevimab
Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others, Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. is a combination medicine ...
, bamlanivimab/etesevimab, and
bamlanivimab
Bamlanivimab is a monoclonal antibody developed by AbCellera Biologics and Eli Lilly as a treatment for COVID-19. The medication was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, and ...
for the treatment of COVID-19. In March 2021, the CHMP concluded that bamlanivimab and etesevimab can be used together to treat confirmed COVID-19 in people who do not require supplemental oxygen and who are at high risk of their COVID-19 disease becoming severe.
[ Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.] The CHMP also looked at the use of bamlanivimab alone and concluded that, despite uncertainties around the benefits of monotherapy, it can be considered a treatment option.
In October 2021, the CHMP ended the rolling review of bamlanivimab/etesevimab.
References
External links
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Emergency Use Authorization (EUA) review for bamlanivimabEmergency Use Authorization (EUA) for bamlanivimab/etesevimabFrequently Asked Questions on the Emergency Use Authorization for bamlanivimab and etesevimab
{{DEFAULTSORT:Bamlanivimab Etesevimab
Combination antiviral drugs
COVID-19 drug development
Monoclonal antibodies