bebtelovimab

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.

Does bebtelovimab attenuate the endogenous immune response to SARS-CoV-2?

Analyses on immune response attenuation and potential SARS-CoV-2 reinfection have not been conducted as part of the BLAZE-4 analysis of bebtelovimab.

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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 Health Care Providers 

Warnings

There are limited clinical data available for bebtelovimab. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use.1

Immune Response Attenuation

There is a theoretical risk that antibody administration may attenuate the endogenous immune response to SARS-CoV-2 and make patients more susceptible to re-infection.1

Bebtelovimab Available Clinical Data

BLAZE-4 Clinical Trial Overview With Bebtelovimab

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

The primary endpoint in the placebo-controlled arms (low-risk patients) was the proportion of patients with persistently high viral load (PHVL) by day 7 and in the open-label arms (high-risk patients) was characterization of the bebtelovimab safety profile.1

Immune Response Attenuation

Analyses on immune response attenuation and potential SARS-CoV-2 reinfection have not been conducted as part of the BLAZE-4 analysis of bebtelovimab. 

Enclosed Fact Sheet for Healthcare Providers

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 February 11, 2022. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf

Date of Last Review: February 14, 2022


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