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bamlanivimab and etesevimab together
bamlanivimab and etesevimab together
700mg/1400mgThis information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What was the effect of bamlanivimab and etesevimab together treatment on preventing hospitalization and deaths?
Patients treated with bamlanivimab 700 mg and etesevimab 1400 mg had an 87% reduction in COVID-related hospitalizations or death of any cause relative to placebo.
Bamlanivimab and Etesevimab Emergency Use Authorization
Bamlanivimab and etesevimab have not been approved, but have only been authorized for emergency use by Food and Drug Administration (FDA) for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab and etesevimab under Section 564(b)(1)(C) of the Act, 21 U.S.C. 360bbb-3, unless the authorization is terminated or revoked sooner.1,2
Bamlanivimab and etesevimab are authorized to be administered together in adults and pediatric patients, including neonates, who are at high risk for progression to severe coronavirus disease 2019 (COVID-19), including hospitalization or death for
For information on the authorized use of bamlanivimab and etesevimab together and mandatory requirements under the emergency use authorization (EUA), please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com. 1,2
Bamlanivimab and Etesevimab Available Clinical Data
The information presented in the sections below contain data on unauthorized doses of bamlanivimab and etesevimab administered together. Please see the enclosed Fact Sheet for authorized dosing information.
BLAZE-1 Clinical Trial Design
BLAZE-1 is an ongoing phase randomized, double-blind, placebo-controlled trial evaluating bamlanivimab and etesevimab together, in non-hospitalized patients with mild to moderate COVID-19.3,4
BLAZE Clinical Trial Designs provides a summary of the BLAZE-1 clinical trial design.
|
BLAZE-1 Phase 3 (NCT04427501) |
|
Design |
Randomized, double-blind, placebo-controlled trial in non-hospitalized patients with mild to moderate COVID-19 and at least 1 risk factorb for developing severe COVID-19 illness |
|
Primary Endpoint |
Percentage of participants who experience COVID-related hospitalization or death through day 29. |
|
Treatment arms included in analyses |
Patients randomized to IV infusion of
|
Patients randomized to IV infusion of
|
Abbreviations: BAM = bamlanivimab; BMI = body mass index; CKD = chronic kidney disease; COPD = chronic obstructive pulmonary disease; COVID-19 = coronavirus disease 2019; CVD = cardiovascular disease; ETE = etesevimab; IV = intravenous.
aBLAZE clinical trials are ongoing studies, outcomes measures, inclusion/exclusion criteria, and eligibility may change throughout the study.
bRisk factors include: ≥ 65 years of age, BMI ≥ 35, CKD, type 1 or type 2 diabetes, immunosuppressive disease, receiving immunosuppressive treatment; ≥ 55 years of age AND have a history of CVD, or hypertension, or COPD or other chronic respiratory disease; 12-17 years of age AND satisfy at least one of the following at the time of screening: BMI ≥85th percentile for their age and gender based on CDC growth charts, sickle cell disease, congenital or acquired heart disease, neurodevelopmental disorders (for example, cerebral palsy), medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation not related to COVID-19), asthma or reactive airway or other chronic respiratory disease, type 1 or type 2 diabetes, immunosuppressive disease, or currently receiving immunosuppressive treatment.
Results With Bamlanivimab and Etesevimab Treatment
Authorized Dose
The dosage for treatment of COVID-19 in adults (18 years and older) and pediatric patients (<18 years and weighing at least 40 kg) is 700-mg bamlanivimab and 1400-mg etesevimab.1
The dosage for pediatric patients weighing less than 40 kg will vary depending on body weight
- >20 kg to <40 kg: 350 mg bamlanivimab and 700 mg etesevimab
- >12 kg to 20 kg: 175 mg bamlanivimab and 350 mg etesevimab
- 1 kg to 12 kg: 12 mg/kg bamlanivimab and 24 mg/kg etesevimab1
Baseline Demographics
Baseline demographics and disease characteristics were well balanced across treatment groups for each of the studies.1BLAZE Clinical Trials Baseline Demographics and Disease Characteristics provides information by study.
BLAZE-1 Phase 3 |
BLAZE-1 Phase 3 |
|
Included treatment arms |
|
|
Total N |
N=1035 |
N=769 |
Median age, years |
56 |
56 |
≥ 65 years old |
31% |
30% |
Female |
52% |
53% |
White |
87% |
87% |
Hispanic or Latino |
29% |
27% |
Black or African American |
8% |
8% |
High-riska for severe COVID-19 illness |
100% |
99.2% |
Mild COVID-19 |
77% |
76% |
Moderate COVID-19 |
23% |
24% |
Mean duration of symptoms, days |
4 |
4 |
Mean viral load by CT |
24 |
24 |
Abbreviations: BAM = bamlanivimab; BMI = body mass index; CKD = chronic kidney disease; COVID-19 = coronavirus disease 2019; CT = cycle threshold; CVD = cardiovascular disease; ETE = etesevimab.
aHigh-risk criteria was defined as adults (≥18 years of age) with at least one of the following: age ≥65 years, BMI ≥35, CKD, diabetes, immunosuppressive disease, immunosuppressant treatment, or age ≥55 years with CVD, hypertension, chronic pulmonary disease or other chronic respiratory disease. Participants ages 12-17 were also enrolled in the trial and met high-risk criteria as defined in the trial protocol.
BLAZE-1 Phase 3: Hospitalizations or Deaths
In the phase 3 portion of the BLAZE-1 trial, >99% of patients enrolled in these dose arms met the criteria for high-risk. Patients were treated with a single IV infusion of
- bamlanivimab 700 mg and etesevimab 1400 mg (N=511)
- bamlanivimab 2800 mg and etesevimab 2800 mg (N=518), or
- placebo.1
In the phase 3 portion of the BLAZE-1 study, the primary endpoint was the number of COVID-19 related hospitalizations (defined as ≥24 hours of acute care) or death by any cause by Day 29.1
Compared to placebo, there were significantly less hospitalizations or deaths in patients treated with bamlanivimab and etesevimab together (p<.001). See full details in Hospitalizations or Deaths by Day 29 in BLAZE-1 Phase 3.1
|
Placebo |
BAM 700 mg |
Placebo |
BAM 2800 mg |
Hospitalizations or deaths, n (%)a |
15 (6%) |
4 (0.8%) |
36 (7%) |
11 (2%) |
% reduction vs placebo |
87% |
70% |
||
p-value vs placebo |
<.0001 |
<.001 |
||
Abbreviations: BAM = bamlanivimab; ETE = etesevimab
aIncludes hospitalizations defined as ≥24 hours of acute care or death by any cause by Day 29.
Hospitalizations
Details related to hospitalizations are presented in BLAZE-1 Phase 3 Hospitalizations.
|
Placebo |
BAM 700 mg + ETE 1400 mg |
Placebo |
BAM 2800 mg + ETE 2800 mg |
Hospitalizations, n (%)a |
14 (5.4) |
4 (0.8) |
33 (6) |
11 (2) |
Duration of hospitalizations, mean days (SD) |
13.5 (7.5) |
7.3 (3.3) |
11.2 (10.1) |
7.3 (6.4) |
RRR |
- |
86% |
- |
68%b |
ARR |
- |
4.6% |
- |
4.5%b |
NNT |
- |
22 |
- |
22 |
Abbreviations: ARR = absolute risk reduction; BAM = bamlanivimab; ETE = etesevimab; Max = maximum; Min = minimum; NNT = number needed to treat; RRR = relative risk reduction.
aDefined as ≥24 hours of acute care.
bCalculation based on n=34 events in placebo group that included a recorded hospitalization in a patient with missing duration information.
Deaths
In the BLAZE-1 trial there were
- no deaths in patients treated with bamlanivimab and etesevimab, and
- 14 deaths in patients treated with placebo.1
All deaths occurred in the BLAZE-1 phase 3 portion of the study.1
Based on phase 3 analyses the NNT by treatment dose for COVID-19 related deaths is
- 58 for bamlanivimab 2800 mg and etesevimab 2800 mg vs placebo, and
- 60 for bamlanivimab 700 mg and etesevimab 1400 mg vs placebo.6
Enclosed Fact Sheet
Reference
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Fact sheet for healthcare providers. Emergency Use Authorization (EUA) of bamlanivimab and etesevimab. US Food and Drug Administration (FDA). 2021.
2United States Food and Drug Administration. Bamlanivimab and etesevimab FDA Emergency Use Authorization letter. Issued December 22, 2021. Accessed December 22, 2021. http://pi.lilly.com/eua/bam-and-ete-eua-fda-authorization-letter.pdf
3A study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in participants with mild to moderate COVID-19 illness (BLAZE-1). ClinicalTrials.gov identifier: NCT04427501. Updated September 8, 2021. Accessed September 14, 2021. https://www.clinicaltrials.gov/ct2/show/NCT04427501
4Gottlieb RL, Nirula A, Chen P, et al. Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial. JAMA. 2021;325(7):632-644. http://dx.doi.org/10.1001/jama.2021.0202
5Dougan M, Nirula A, Azizad M, et al. Bamlanivimab plus etesevimab in mild or moderate covid-19. N Eng J Med. Published online July 14, 2021. http://dx.doi.org/10.1056/NEJMoa2102685
6Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
ASPR = Assistant Secretary for Preparedness and Response
COVID-19 = coronavirus disease 2019
EUA = emergency use authorization
FDA = Food and Drug Administration
IV = intravenous
SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2
US = United States
Date of Last Review: December 23, 2021