Bebtelovimab
- Generic Name
- Bebtelovimab
- Drug Type
- Biotech
- CAS Number
- 2578319-11-4
- Unique Ingredient Identifier
- 8YL4SYR6CU
- Background
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 On November 30, 2022, the EUA for bebtelovimab was officially withdrawn due to a lack of efficacy against Omicron subvariants, therefore bebtelovimab is no longer authorized for emergency use in the US.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.
FDA Grants Emergency Authorization to Lilly's Bebtelovimab for COVID-19, Securing $720M Government Contract
• 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
• 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.
• Bebtelovimab was no longer authorized for use in regions where SARS-CoV-2 variants demonstrated resistance, based on available susceptibility data and variant frequency.
• The FDA determined that revoking the EUA was necessary to protect public health, given the reduced efficacy against circulating variants and the expiration of existing supplies.
FDA Revokes Emergency Use Authorizations for Four COVID-19 Monoclonal Antibody Products
• 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.
Adaptive Designs and mRNA Advancements Drive Innovation in Vaccine Clinical Trials
• Novotech's report highlights a significant shift towards adaptive trial designs in vaccine development, enabling faster and more flexible responses to global health emergencies.
• mRNA vaccine advancements are key to this shift, demonstrating the need for rapid and adaptable clinical trial frameworks, particularly after the COVID-19 pandemic.
• Prophylactic vaccine trials are dominating the landscape with a 54.9% CAGR between 2019 and 2024, benefiting from the flexibility of adaptive designs.
• AI is increasingly used to improve participant selection, data analysis, and real-time monitoring in vaccine trials, enhancing safety and efficacy.
FDA Revokes Authorization of GSK and Vir's Sotrovimab Due to BA.2 Inefficacy
• 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 Authorizations for Four Monoclonal Antibody Treatments Due to Variant Resistance
• The FDA has revoked the Emergency Use Authorizations (EUAs) for four monoclonal antibody (mAb) products previously used to treat COVID-19 due to persistent resistance from circulating SARS-CoV-2 variants.
• These mAbs have not been authorized for patient administration for over a year because of the high prevalence of SARS-CoV-2 variants against which they are ineffective.
• The decision follows previous FDA announcements limiting the EUAs, allowing facilities to retain inventory in anticipation of potential changes in variant susceptibility, which did not occur.
• With the expiration of the shelf life for nearly all lots of these products, the FDA has formally revoked the EUAs.
FDA Warns Evusheld May Be Ineffective Against COVID-19 Subvariant XBB.1.5
• The FDA has cautioned that Evusheld, a preexposure prophylaxis for COVID-19, may not neutralize the XBB.1.5 subvariant, which accounts for nearly 30% of cases.
• The agency is awaiting further data but suggests that Evusheld's effectiveness is compromised against XBB.1.5 compared to other variants.
• Healthcare providers are advised to inform patients about the increased risk of COVID-19 infection due to the reduced efficacy of Evusheld against certain SARS-CoV-2 variants.
FDA Restricts Emergency Use Authorization for AstraZeneca's Evusheld in the US
• The FDA has restricted the emergency use authorization for AstraZeneca's Evusheld in the US due to the prevalence of resistant SARS-CoV-2 variants.
• Evusheld is not currently authorized for pre-exposure prophylaxis of COVID-19 in the US until the prevalence of resistant variants decreases.
• AstraZeneca is developing a next-generation long-acting antibody that neutralizes all tested SARS-CoV-2 variants, with potential availability in late 2023.
• The US government recommends retaining and properly storing all Evusheld product in case susceptible variants become more prevalent in the future.
FDA Revokes Emergency Use Authorization for Bebtelovimab
• 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.
• Bebtelovimab, a monoclonal antibody infusion treatment developed by Eli Lilly, was previously authorized for treating mild-to-moderate COVID-19 in certain high-risk patients.
• Healthcare providers should discontinue the use of bebtelovimab and consider alternative treatments for COVID-19 that remain effective against current variants.
• MaineCare coverage for bebtelovimab infusions ended on November 30, 2022, coinciding with the FDA's revocation of the EUA.
FDA Restricts Sotrovimab Use Due to Omicron BA.2 Variant Resistance
• The FDA has suspended the authorization of GlaxoSmithKline and Vir Biotechnology's sotrovimab in regions where the Omicron BA.2 subvariant is dominant, citing inefficacy.
• Sotrovimab, a monoclonal antibody, was previously authorized for treating high-risk COVID-19 patients but shows reduced effectiveness against the BA.2 subvariant.
• Eli Lilly's bebtelovimab remains an authorized monoclonal antibody treatment, while oral antivirals also offer alternatives against BA.2.
• GSK and Vir are preparing data on a higher dose of sotrovimab for the Omicron BA.2 subvariant for review by regulatory bodies.
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