bamlanivimab and etesevimab together

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

Bamlanivimab and etesevimab administered together are authorized for the treatment of mild to moderate COVID-19 and post-exposure prophylaxis for prevention of COVID-19 in pediatric patients, including neonates.

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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, including neonates, 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 Fact Sheet for Healthcare Providers

Use in Pediatric Patients

Bamlanivimab and etesevimab administered together are authorized for the treatment of mild to moderate COVID-19 and post-exposure prophylaxis for prevention of COVID-19 in pediatric patients, including neonates. Given the similar course of COVID-19, the authorization of bamlanivimab and etesevimab for treatment and post-exposure prophylaxis in younger pediatric patients, including neonates, is supported by safety and efficacy data in adolescents and adults, together with additional pharmacokinetic and safety data from the clinical trial in pediatric patients studying bamlanivimab and etesevimab for the treatment of mild to moderate COVID-19.1 

Use of bamlanivimab and etesevimab in pediatric patients is based on analyses of data from BLAZE-1 in subjects aged 10 months to 18 years of age. No dosage adjustment is recommended in pediatric patients 12-18 years of age who weigh at least 40 kg. Pediatric patients weighing less than 40 kg should be dosed on the basis of body weight. The recommended dosing regimen for pediatric patients ≤12 kg is predicted based on pharmacokinetic modeling and simulation. The youngest participant in the pediatric clinical trial for treatment was 10 months of age and weighed 8.6 kg. Safety in pediatric patients was similar to what was observed in adults.1 

Children were not enrolled in the post-exposure prophylaxis trial, BLAZE-2. 1

Patient Selection and Treatment Initiation

The following medical conditions or other factors may place adults and pediatric patients, including neonates, at higher risk for progression to severe COVID-19:1 

  • Older age (for example age ≥65 years of age)
  • <1 year old
  • Obesity or being overweight
  • 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])

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

Treatment Dosage

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

For treatment of COVID-19, bamlanivimab and etesevimab should be administered together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.1

Postexposure Prophylaxis Dosage

The dosage for post-exposure prophylaxis in adults (18 years and older) and pediatric individuals (<18 years and weighing at least 40 kg) is 700-mg bamlanivimab and 1400-mg etesevimab administered together as a single IV infusion.1

The dosage for pediatric individuals 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

For post-exposure prophylaxis, bamlanivimab and etesevimab should be given together as soon as possible following exposure to SARS-CoV-2.1 

Pharmacokinetics in Pediatric Patients

The pharmacokinetics of bamlanivimab and etesevimab has been evaluated in 88 pediatric patients <18 years who received weight-based dosing. The data show that weight-based dosing in pediatric patients provides comparable plasma exposures to those observed in adults who received bamlanivimab 700 mg and etesevimab 1400 mg.1 

No dosage adjustment is recommended in pediatric patients <18 years who weigh at least 40 kg. Pediatric patients weighing less than 40 kg should be dosed on the basis of body weight.1 

The recommended dosing regimen for pediatric patients ≤12 kg is predicted to result in similar exposures when compared to exposures achieved in adults receiving bamlanivimab 700 mg and etesevimab 1400 mg based on pharmacokinetic modeling and simulation. The youngest participant in the pediatric treatment trial was 10 months of age and weighed 8.6 kg.1

Clinical Trial Information

Treatment of Mild to Moderate COVID-19 (BLAZE-1)

Pediatric Patients <18 Years

The safety and efficacy of bamlanivimab and etesevimab together was evaluated in a total of 125 pediatric patients enrolled in the phase 2/3 BLAZE-1 trial (NCT04427501), in which patients were treated for mild to moderate COVID-19. Pediatric patients were not hospitalized, and treatment was initiated within 3 days of obtaining the clinical sample for the first positive SARS-CoV-2 viral infection determination. All pediatric patients met the criteria for high-risk. Pediatric patients weighing 40 kg or more received the same dose as adults (700 mg bamlanivimab and 1400 mg etesevimab). Pediatric patients weighing less than 40 kg received weight-based dosing.1

Of the 125 pediatric subjects, 33 subjects ages 12 to <18 were evaluated in double-blind, placebo-controlled Phase 3 cohorts of BLAZE-1, and 1 subject age 12 to <18 was evaluated in a controlled addendum to BLAZE-1. Of the 33 pediatric subjects,

  • 14 received placebo,
  • 14 received the authorized dose or a higher dose for their age, and
  • 5 received a lower dose than authorized for their age.1 

A total of 91 pediatric subjects were evaluated in an open-label addendum to BLAZE-1, with

  • 40 subjects ages 12 to <18,
  • 36 ages 6 to <12,
  • 10 ages 2 to <6, and
  • 5 ages 0 to <2.1 

The youngest participant in the trial was 10 months of age and weighed 8.6 kg.1 

Baseline Characteristics

All pediatric patients had at least one risk factor for the development of severe COVID-19 illness.1

 Baseline Characteristics of Pediatric Patients Who Received Bamlanivimab and Etesevimab Together for the Treatment of COVID-19 shows baseline characteristics of pediatric patients who received bamlanivimab and etesevimab together for the treatment of COVID-19 in BLAZE-1.

 Baseline Characteristics of Pediatric Patients Who Received Bamlanivimab and Etesevimab Together for the Treatment of COVID-191


BLAZE-1 Trial (N=125)

Median age, years

12

Female, %

46

Race/ethnicity, %

White

38

Hispanic or Latino

20

Black or African-American

57

COVID-19 severity, %

Mild

88

Moderate

12

Mean duration of symptoms, days

4

Mean baseline viral load by cycle threshold

5.92

Results

No pediatric patients died or required hospitalization due to COVID-19.1

The change in viral load to day 7 by dose was

  • -4.23 for patients treated with 700 mg bamlanivimab and 1400 mg etesevimab (n=9), and
  • -4.23 for patients who received weight-based dosing with bamlanivimab and etesevimab (n=75).1

The median time to complete symptom resolution as recorded in a trial-specific daily symptom diary was

  • 7 days for patients treated with bamlanivimab 700 mg and etesevimab 1400 mg together (n=10), and
  • 5 days for patients treated with weight-based dosing of bamlanivimab and etesevimab together (n=91).1

Symptoms assessed were

  • shortness of breath
  • nasal congestion
  • fever
  • chills
  • sore throat
  • stomachache
  • nausea
  • vomiting
  • diarrhea
  • cough
  • tiredness
  • muscle or body aches
  • headache
  • new loss of smell
  • new loss of taste, and
  • poor appetite or poor feeding.1

Complete symptom resolution was defined as absence of all symptoms at a single timepoint. 1

The adverse drug reaction profile in pediatric patients is consistent with the established profile.1

Bamlanivimab and Etesevimab Available Clinical Data

Additional Safety Data from BLAZE-1 Clinical Trial 

A total of 16 (12.8%) patients had a treatment-emergent adverse event (TEAE), all of which occurred in patients who received bamlanivimab and etesevimab together (see Treatment-Emergent Adverse Events in the Pediatric Safety Population of BLAZE-1), including

  • 14 patients who received weight-based dosing of bamlanivimab and etesevimab
  • 1 patient who received bamlanivimab 700 mg plus etesevimab 1400 mg, and
  • 1 patient who received bamlanivimab 350 mg plus etesevimab 700 mg via rapid intravenous (IV) infusion over 3 minutes.3

No TEAEs occurred in ≥5% of the total study participants.3

Most of the TEAEs were mild or moderate in severity. One TEAE was categorized as severe. No serious adverse events were reported and no patients discontinued from study treatment due to an adverse event.3

Treatment-Emergent Adverse Events in the Pediatric Safety Population of BLAZE-13

MedDRAa Preferred Term, n (%)

Total (N=125)

Investigations SOCb

Blood creatine phosphokinase increased

6 (4.8)c

White blood cell count decreased

5 (4.0)

Monocyte count decreased

3 (2.4)

Neutrophil count decreased

2 (1.6)

Alanine aminotransferase increased

1 (0.8)

Aspartate aminotransferase increased

1 (0.8)

Blood alkaline phosphatase decreased

1 (0.8)

Blood alkaline phosphatase increased

1 (0.8)

Blood lactate dehydrogenase increased

1 (0.8)

Lipase increased

1 (0.8)

Lymphocyte count decreased

1 (0.8)

Serum ferritin increased

1 (0.8)

Rashd

1 (0.8)

Rash papulare

1 (0.8)

Infusion site extravasationf

1 (0.8)

Arthralgiae

1 (0.8)

Epistaxise

1 (0.8)

 Abbreviation: MedDRA = Medical Dictionary for Regulatory Activities; SOC = System Organ Class.

aVersion 24.0

bAll TEAEs occurred in patients who received open-label weight-based dosing.

cOne case was reported as severe.

dPatient received treatment with bamlanivimab 700 mg and etesevimab 1400 mg together.

ePatient received open-label, weight-based dosing.

fPatient received bamlanivimab 350 mg plus etesevimab 700 mg via rapid intravenous infusion over 3 minutes.

No pediatric patients had a hypersensitivity or infusion-related reaction within 24 hours of infusion. One patient who received bamlanivimab 700 mg and etesevimab 1400 mg together had a rash more than 24 hours after infusion.3

Post-exposure Prophylaxis of COVID-19 (BLAZE-2)

BLAZE-2 was a phase 3 trial conducted in partnership with the National Institute of Allergy and Infectious Disease (NIAID). 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.4

In order to be eligible for enrollment in BLAZE-2, patients must be ≥18 years of age.4

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

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

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4A 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: December 23, 2021


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