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bebtelovimab
bebtelovimab
175mgThis 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.
Can bebtelovimab be used in pediatric patients?
The FDA has issued an EUA for the emergency use of bebtelovimab for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg). No dosage adjustment is recommended.
Bebtelovimab Emergency Use Authorization
Bebtelovimab has not been approved, but has 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 bebtelovimab 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
Bebtelovimab is authorized for the treatment of mild-to-moderate coronavirus disease 2019 (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 progression to severe COVID-19, including hospitalization or death, and
- for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.1,2
For information on the authorized use of bebtelovimab 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/bebtelovimab. 1,2
Bebtelovimab Fact Sheet for Healthcare Providers
High-Risk Factors
For 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/hcp/clinical-care/underlyingconditions.html. Healthcare providers should consider the benefit-risk for an individual patient.1
Recommended Dose in Pediatric Patients
Bebtelovimab is not authorized for use in pediatric individuals under 12 years of age or weighing less than 40 kg. The safety and effectiveness of bebtelovimab have not been assessed in pediatric patients. The recommended dosing regimen in patients 12 years to less than 18 years of age, weighing at least 40 kg, is expected to result in comparable serum exposures of bebtelovimab as those observed in adults.1
The dosage in adults (18 years and older) and pediatric patients (≥12 years of age and weighing at least 40 kg) is bebtelovimab 175 mg.1
Administer bebtelovimab as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.1
Bebtelovimab must be administered as a single intravenous injection over at least 30 seconds.1
Bebtelovimab Available Clinical Data
BLAZE-4
BLAZE-4 is a phase 2, randomized, single-dose clinical trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19.1
Bebtelovimab was among the treatment interventions studied in BLAZE-4. It was evaluated alone and together with bamlanivimab and etesevimab in
- low-risk adults (ie, those not at high-risk to progress to severe COVID-19) and compared to a placebo control arm, and
- high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments.1
Because there are other therapeutic options available, a placebo control could not be used to treat high-risk patients.1
In the open-label randomized portion of the trial (treatment arms 12-13), patients were treated with a single infusion of
- bamlanivimab 700 mg, etesevimab 1400 mg, and bebtelovimab 175 mg (N=50), or
- bebtelovimab 175 mg alone (N=100).1
There were 2 pediatric patients enrolled (ages 14 and 17), one in each treatment arm.1
In the open-label non-randomized portion of the trial (treatment 14), patients were treated with a single infusion of bamlanivimab 700 mg, etesevimab 1400 mg, and bebtelovimab 175 mg (N=176).
There were 2 pediatric patients were enrolled (ages 14 and 15).1
Separate efficacy or safety subgroup analyses have not been conducted to date for patients 12 to 17 years old.3
Pharmacokinetic Modeling
The interim population pharmacokinetic (PK) dataset for bebtelovimab included participants from the low- and high-risk populations from BLAZE-4 treated with bebtelovimab 175 mg alone and together with bamlanivimab 700 mg and etesevimab 1400 mg.3
Population PK modeling found that drug exposure in pediatric patients (12 years of age and older weighing at least 40 kg) is expected to be similar to adults (weight range: 45-194 kg). Therefore, the same bebtelovimab 175-mg dose is proposed based on exposure matching (see Bebtelovimab Concentration-Time Profile in Adults and Adolescents (Weighing at Least 40 kg)).3
Figure description: Bebtelovimab drug concentrations in adolescents weighing at least 40 kg are predicted to be similar to those in adults for a bebtelovimab 175-mg dose.
Note: The 90% prediction interval represents the range of data from the 5th to the 95th percentile, depicting where 90% of drug concentrations are predicted to lie.
Use in Pediatric Patients <12 Years Old
Pediatric patients <12 years old were not included in the BLAZE-4 trial.3
BLAZE-1 Bebtelovimab Pediatric Addendum
The PK and safety of bebtelovimab in pediatric patients is being assessed in the BLAZE-1 clinical study (NCT04427501) as part of a trial addendum.4 Currently, this study is no longer enrolling new patients due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab.3
Description of BLAZE-1 Bebtelovimab Pediatric Addendum provides a brief description of the BLAZE-1 bebtelovimab pediatric addendum.
The BLAZE-1 trial bebtelovimab amendment for pediatric patients does not include bamlanivimab or etesevimab dosing groups.4
Primary Objective |
Assess PK in the pediatric population after IV injection of bebtelovimab using AUC from 0 to infinity. |
Secondary Objective |
Safety description via assessments such as adverse events and serious adverse events. |
Patient population |
SARS-CoV-2 positive pediatric patients with mild to moderate disease that are
|
Treatment arm |
Open-label IV bebtelovimab dose based on weight |
Key Inclusion Criteria |
|
Key Exclusion Criteria |
|
Location |
United States |
Abbreviations: AUC = area under the concentration-time curve; COVID-19 = coronavirus disease 2019; IV = intravenous; PK = pharmacokinetic; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; SOB = shortness of breath; SpO2 = oxygen saturation.
Enclosed Fact Sheet
References
1Fact sheet for healthcare providers. Emergency Use Authorization (EUA) of bebtelovimab. US Food and Drug Administration (FDA). 2022.
2United States Food and Drug Administration. Bebtelovimab FDA Emergency Use Authorization letter. Issued October 27, 2022. Accessed December 1, 2022. http://pi.lilly.com/eua/bebtelovimab-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 participants with mild to moderate COVID-19 illness (BLAZE-1). ClinicalTrials.gov identifier: NCT04427501. Updated August 31, 2022. Accessed September 2, 2022. https://www.clinicaltrials.gov/ct2/show/NCT04427501
Date of Last Review: December 01, 2022