bamlanivimab and etesevimab together

This 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 information is available regarding the use of bamlanivimab and etesevimab in pediatric patients?

The safety and efficacy of BAM/ETE for treatment are being assessed in clinical trials for pediatric use. BAM/ETE can be used for treatment and prevention in patients ≥12 yrs, weighing ≥40 kg who are at high risk for progressing to severe COVID-19.

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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 (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe coronavirus disease 2019 (COVID-19), including hospitalization or death for

  • the treatment of mild to moderate COVID-19, or
  • post-exposure prophylaxis of COVID-19.1,2    

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 are not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%, as determined by FDA. A list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available on the following FDA website: https://www.fda.gov/media/151719/download. 1,2    

Bamlanivimab and Etesevimab Fact Sheet for Healthcare Providers

Patient Selection and Treatment Initiation

The following medical conditions or other factors may place adults and pediatric patients (12 years of age and older weighing at least 40 kg) at higher risk for progression to severe COVID-19:

  • Older age (for example age ≥65 years of age)
  • Obesity or being overweight (for example, adults with BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on Centers for Disease Control and Prevention (CDC) growth charts  (https://www.cdc.gov/growthcharts/clinical_charts.htm)
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or immunosuppressive treatment
  • Cardiovascular disease (including congenital heart disease) or hypertension
  • Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, and pulmonary hypertension)
  • Sickle cell disease
  • Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
  • Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19])1

Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of bamlanivimab and etesevimab under the EUA is not limited to the medical conditions or factors listed above. For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Healthcare providers should consider the benefit-risk for an individual patient.1

    Recommended Dose in Pediatric Patients

    The dosage for treatment of COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is bamlanivimab 700 mg and etesevimab 1400 mg administered together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.1

    The dosage for postexposure prophylaxis in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) is 700 mg bamlanivimab and 1400 mg etesevimab administered together as soon as possible following exposure to SARS-CoV-2.1

    No dosage adjustment is recommended in pediatric patients who weigh at least 40 kg and are 12 years of age and older. Bamlanivimab and etesevimab are not authorized for patients weighing less than 40 kg or those less than 12 years of age.1

    Pharmacokinetics in Pediatric Patients

    The pharmacokinetics of bamlanivimab and etesevimab at the authorized dose has been evaluated in 10 pediatric patients ages 12 years or older who weigh at least 40 kg. The data show that the plasma exposures in these patients are comparable to what has been observed in adult patients. The pharmacokinetics of bamlanivimab and etesevimab has not been evaluated in pediatric patients ages <12 years who weigh <40 kg.1

    Use in Pediatric Patients

    The safety and effectiveness of bamlanivimab and etesevimab administered together are being assessed in adolescent patients in ongoing clinical trials.1

    Phase 3 Data From BLAZE-1 (Bamlanivimab 700 mg and Etesevimab 1400 mg)

    In this portion of the BLAZE-1 phase 3 clinical trial, subjects were treated with a single infusion of bamlanivimab 700 mg and etesevimab 1400 mg (N=511) or placebo (N=258). The majority (99.2%) of the patients enrolled in these dose arms met the criteria for high-risk adults (≥18 years of age) that included at least one of the following:

    • age ≥65 years
    • BMI ≥35
    • chronic kidney disease
    • diabetes
    • immunosuppressive disease
    • immunosuppressant treatment, or
    • age ≥55 years with
      • cardiovascular disease
      • hypertension, or
      • chronic pulmonary disease or other chronic respiratory disease.1 

    Participants ages 12 to 17 were also enrolled in the trial (10 [2.0%] were treated with bamlanivimab and etesevimab and 13 [1.7%] were treated with placebo), and met high-risk criteria as defined in the trial protocol.1 

    Phase 3 Data From BLAZE-1 (Bamlanivimab 2800 mg and Etesevimab 2800 mg)

    Subjects were treated with a single infusion of bamlanivimab 2800 mg and etesevimab 2800 mg (N=518) or placebo (N=517). All of the patients enrolled in these dose arms met the criteria for high-risk adults (≥18 years of age) that included at least one of the following:1

    • age ≥65 years of age
    • body mass index (BMI) ≥35
    • chronic kidney disease
    • diabetes
    • immunosuppressive disease
    • immunosuppressant treatment, or
    • age ≥55 years with
      • cardiovascular disease
      • hypertension, or
      • chronic pulmonary disease or other chronic respiratory disease.

    Participants ages 12 to 17 years were also enrolled in the trial (4 [0.8%] were treated with bamlanivimab and etesevimab and 7 [1.4%] were treated with placebo), and met high-risk criteria as defined in the trial protocol.1

    Bamlanivimab and Etesevimab Available Clinical Data

    BLAZE-1 Clinical Trial

    BLAZE-1 (NCT04427501) is a randomized, double-blind, placebo-controlled ongoing phase 2/3 study designed to assess the efficacy and safety of bamlanivimab and etesevimab together or bamlanivimab alone for the treatment of symptomatic COVID-19 in the outpatient setting.3,4

    BLAZE-1 Inclusion Criteria Related to Age

    Initial inclusion criteria for BLAZE-1 specified that patients 18 years or older were eligible for enrollment.4

    As the BLAZE-1 clinical trial continues to progress, currently, pediatric patients of all ages are eligible for enrollment.3

    However, at this time, no data are available regarding bamlanivimab and etesevimab treatment together for pediatric patients <12 years of age with COVID-19.5

    Baseline Demographics of Pediatric Patients Ages 12 to 17 Years

    A total of 44 patients ages 12 to ≤17 years have been included in the BLAZE-1 clinical trial. Baseline Demographics and Risk Factors in Pediatric Patients Ages 12 to ≤17 Years in BLAZE-1 provides the baseline demographics and risk factors for patients who received the authorized dose of bamlanivimab 700 mg and etesevimab 1400 mg and other explored doses.5 

    Baseline Demographics and Risk Factors in Pediatric Patients Ages 12 to ≤17 Years in BLAZE-15

     

    Placebo
    N=14

    BAM 700 mg + ETE 1400 mg
    N=10

    BAM 2800 mg + ETE 2800 mg
    N=4

    Totala
    N=44

    Female, n (%)

    5 (35.7)

    7 (70.0)

    1 (25.0)

    22 (50.0)

    Age, mean years (min, max)

    14.9 (12, 17)

    14.9 (12, 17)

    14.3 (13, 17)

    14.8 (12, 17)

    Weight category, n (%)

    <60 kg

    3 (21.4)

    2 (20.0)

    0

    7 (15.9)

    ≥60 to <100 kg

    9 (64.3)

    7 (70.0)

    3 (75.0)

    26 (59.1)

    ≥100 kg

    2 (14.3)

    1 (10.0)

    1 (25.0)

    11 (25.0)

    BMI, mean (SD) kg/m2

    26.6 (5.7)

    28.9 (6.3)

    31.4 (3.1)

    30.0 (8.8)

    Mild COVID-19, n (%)

    12 (85.7)

    5 (50.0)

    4 (100.0)

    36 (81.8)

    Moderate COVID-19, n (%)

    2 (14.3)

    5 (50.0)

    0

    8 (18.2)

    Duration of symptoms onset, mean days (SD)

    4.0 (3.0)

    2.7 (2.8)

    4.0 (1.4)

    3.6 (2.5)

    High riskb for severe COVID-19 illness, n (%)

    9 (64.3)

    9 (90.0)

    4 (100.0)

    36 (81.8)

    Number of high risk criteria met

    0

    5 (35.7)

    1 (10.0)

    0

    8 (18.2)

    1

    8 (57.1)

    9 (90.0)

    4 (100.0)

    35 (79.5)

    2

    1 (7.1)

    0

    0

    1 (2.3)

    BMI ≥85th percentile

    9 (64.3)

    8 (80.0)

    4 (100.0)

    34 (77.3)

    Diabetes

    1 (7.1)

    0

    0

    1 (2.3)

    Immunosuppressive Treatment

    0

    1 (10.0)

    0

    2 (4.5)

    Immunosuppressive disease

    0

    0

    0

    0

    Chronic kidney disease

    0

    0

    0

    0

    Sickle cell disease

    0

    0

    0

    0

    Congenital or acquired heart disease

    0

    0

    0

    0

    Neurodevelopmental disorders

    0

    0

    0

    0

    Medical-related technological dependence

    0

    0

    0

    0

    Asthma or other chronic respiratory disease

    0

    0

    0

    0

     Abbreviations: BAM = bamlanivimab; BMI = body mass index; COVID-19 = coronavirus disease 2019; ETE = etesevimab; max = maximum; min = minimum.

    aTotal 12-17 year old population includes placebo, BAM 700 mg + ETE 1400 mg, BAM 2800 mg + ETE 2800 mg, and other exploratory doses.

    bHigh risk for pediatric patients was defined as ages 12-17 years AND satisfy at least one of the following criteria at the time of screening: are pregnant, BMI ≥85th percentile by age and gender (based on CDC growth charts), have sickle cell disease, have congenital or acquired heart disease, have neurodevelopmental disorders (ex. cerebral palsy), have a medical-related technological dependence, (ex. tracheostomy, gastrostomy, or non-COVID related positive pressure ventilation), have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control, have type 1 or type 2 diabetes, have chronic kidney disease, have immunosuppressive disease, or are currently receiving immunosuppressive treatment.

    Efficacy and Safety in Pediatric Patients Ages 12 to  Years

    Separate efficacy or safety subgroup analyses have not been conducted to date for patients 12 to 17 years old.5

    BLAZE-2 Clinical Trial 

    BLAZE-2 was a phase 3 trial conducted in partnership with the NIH. The study was designed to evaluate bamlanivimab alone and in combination with etesevimab for post-exposure prophylaxis of COVID-19 in residents and workers in skilled nursing and assisted living facilities at high risk for SARS-CoV-2 exposure.6

    In order to be eligible for enrollment in BLAZE-2, patients must be ≥18 years of age.6

    Therefore, there is no available data regarding the use of bamlanivimab and etesevimab for post-exposure prophylaxis of COVID-19 in patients <18 years of age. 

    References

    The published references below are 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 September 16, 2021. Accessed September 16, 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 August 24, 2021. Accessed September 3, 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

    5Data on file, Eli Lilly and Company and/or one of its subsidiaries.

    6A study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in preventing SARS-CoV-2 infection and COVID-19 in nursing home residents and staff (BLAZE-2). ClinicalTrials.gov identifier: NCT04497987. Updated July 6, 2021. Accessed September 3, 2021. https://www.clinicaltrials.gov/ct2/show/NCT04497987

    Date of Last Review: September 03, 2021


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