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On February 25, 2021, Eli Lilly and Company received an Emergency Use Authorization (EUA, PDF) from the U.S. Food and Drug Administration (FDA) for the investigational monoclonal antibody (mAb) treatment bamlanivimab/etesevimab.
The EUA allows healthcare providers to administer bamlanivimab/etesevimab together to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Treatment should be initiated as soon as possible after a positive viral test for SARS-CoV2 (either antigen or molecular PCR test) and within 10 days of symptom onset.
Bamlanivimab/etesevimab was shown to lower incidence of Covid-19-related hospitalization and death in high-risk ambulatory patients in a clinical trial.
Clinical trial data have not shown a benefit with bamlanivimab/etesevimab use in patients hospitalized patients or patients requiring high-flow oxygen or mechanical ventilation, and it is not authorized for use in patients who are hospitalized due to COVID-19.
On September 16, 2021, the FDA revised the EUA for bamlanivimab/etesevimab to include post-exposure prophylaxis (PDF) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.
Post-exposure prophylaxis can be given to high-risk individuals if:
Use of bamlanivimab/etesevimab as a post-exposure prophylaxis is not a replacement for COVID-19 vaccination. The product should not be used as a pre-exposure prophylaxis.
As of September 2, 2021, bamlanivimab/etesevimab is effective against variants circulating in California, and is authorized (PDF) for use in California by the FDA.
Distribution of bamlanivimab/etesevimab was paused in California on May 26, 2021 to September 2, 2021, because it had decreased effectiveness against variants that were circulating at that time (specifically, Gamma [P.1] and Beta [B.1.351]).
Distribution of bamlanivimab/etesevimab resumed in the state on September 2, 2021 as the Delta (B.1.617.2) variant became predominant in California.
The vast majority of Delta variant lineages are sensitive to bamlanivimab/etesevimab. The combination of the L452R and T478K substitutions found in most Delta variants results in no change in the susceptibility to the combination of bamlanivimab and etesevimab, as noted in the FDA Fact Sheet for Health Care Providers (PDF). Delta sublineages AY.1 and AY.2 (which include the mutation K417N) are resistant to bamlanivimab/etesevimab. Currently these resistant sublineages make up a very small proportion of circulating virus in the United States and in California.
The FDA EUA includes additional information on in vitro susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody therapies. The revised EUA (PDF), which includes this data as well as the full conditions of use, should be reviewed prior to administration of the medication.
Additional considerations of use include the following:
The NIH COVID-19 Treatment Guidelines Panel recommends using one of the following anti-SARS-CoV-2 mAb regimens (listed alphabetically) to treat non-hospitalized patients with mild to moderate COVID-19 who are at high risk of clinical:
The Panel also states the following:
The Infectious Diseases Society of America (IDSA) Guideline Panel recommends the use of bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab rather than no neutralizing antibody treatment among ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease.
Given high demand and limited supply, the U.S. Department of Health and Human Services (HHS) announced that effective September 13, 2021, distribution of the anti-SARS-CoV-2 monoclonal antibody products casirivimab plus imdevimab (PDF) and bamlanivimab plus etesevimab will transition to a state/territory-coordinated distribution system. Facilities can no longer directly order this product.
Weekly distribution amounts for each state/territory will be determined by HHS based on weekly reports of new COVID-19 cases and hospitalizations in addition to data on inventories and use submitted to the federal government.
CDPH will be allocating product to local jurisdictions. Once the number of doses has been allocated, each jurisdiction's Medical and Health Operational Area Coordinator (MHOAC) will assist in determining which facilities within the jurisdiction receive product.
Originally published on March 9, 2021