Bebtelovimab

Overview

Bebtelovimab (LY-COV1404, LY-3853113) is a human monoclonal antibody approved for emergency use in the treatment of COVID-19. It binds to a portion of the SARS-CoV-2 spike (S) protein's receptor-binding domain, thereby preventing spike protein interaction with ACE2 and subsequent viral entry into host cells. Bebtelovimab is notable in that the epitope to which it binds appears infrequently mutated, making it a viable candidate for use in resistant SARS-CoV-2 strains (i.e. variants of concern, VOCs), including the B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants. This is in contrast to previously developed COVID-19 monoclonal antibody treatments - including bamlanivimab, etesevimab, casirivimab, and imdevimab - which have been found ineffective in the treatment of COVID-19 caused by the Omicron variant. Bebtelovimab was issued an emergency use authorization (EUA) by the FDA on February 11, 2022, for the treatment of mild-to-moderate COVID-19 in select patients. In November 2022, the FDA updated the Health Care Provider Fact Sheet for bebtelovimab to inform of its expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. On November 30, 2022, the EUA for bebtelovimab was officially withdrawn due to a lack of efficacy against Omicron subvariants, therefore bebtelovimab is no longer authorized for emergency use in the US.

Indication

Bebtelovimab currently has no approved indications.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness	2020/11/18	NCT04634409	Phase 2	Completed	Eli Lilly and Company
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness	2020/06/11	NCT04427501	Phase 2	Completed	Eli Lilly and Company

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Bebtelovimab	Eli Lilly and Company	0002-7589	INTRAVENOUS	87.5 mg in 1 mL	2/11/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

FDA Grants Emergency Authorization to Lilly's Bebtelovimab for COVID-19, Securing $720M Government Contract

6 months ago

• The FDA has granted emergency use authorization to Eli Lilly's bebtelovimab for treating mild-to-moderate COVID-19 in high-risk patients aged 12 and older. • The US government has placed a $720 million order for up to 600,000 doses of bebtelovimab, with initial deliveries expected by March end. • Clinical data shows bebtelovimab retains full neutralizing activity against the Omicron variant and its subvariants, offering a crucial treatment option as other antibody therapies lose effectiveness.

FDA Revokes Emergency Use Authorization for Bebtelovimab Due to Expired Lots and Variant Resistance

7 months ago

The FDA revoked the Emergency Use Authorization (EUA) for bebtelovimab on December 5, 2024, following a request from Lilly due to the expiration of all manufactured lots.

FDA Revokes Emergency Use Authorizations for Four COVID-19 Monoclonal Antibody Products

8 months ago

• The FDA has revoked the Emergency Use Authorizations (EUAs) for four monoclonal antibody products used in the U.S. government's COVID-19 response. • The revoked EUAs include treatments from Eli Lilly, AstraZeneca, Vir Biotechnology, and Regeneron Pharmaceuticals due to the rise of resistant SARS-CoV-2 variants. • These monoclonal antibody products have not been authorized for patient administration for over a year because of ineffective against current variants. • Healthcare facilities will receive instructions from the sponsors for the return and disposal of the revoked products.

FDA Revokes Authorization of GSK and Vir's Sotrovimab Due to BA.2 Inefficacy

10 months ago

• The FDA has fully revoked the emergency use authorization for GlaxoSmithKline and Vir Biotechnology's sotrovimab due to its reduced efficacy against the Omicron sub-variant BA.2. • Sotrovimab initially received EUA based on Phase III trial data showing an 85% reduction in hospitalization or death risk for high-risk COVID-19 patients. • Despite GSK and Vir's claims of efficacy with higher doses, the FDA's decision reflects broader concerns about the treatment's ability to neutralize BA.2. • GSK and Vir plan to submit for full approval of sotrovimab and initiate trials to assess its potential in preventing symptomatic COVID-19 in immunocompromised individuals.

FDA Revokes Emergency Use Authorization for Bebtelovimab

3 years ago

The FDA revoked the Emergency Use Authorization (EUA) for bebtelovimab 175mg on November 30, 2022, due to its diminished efficacy against emerging COVID-19 variants.

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