Monoclonal antibody stands out from omicron subvariants: a call to action for wider access to bebtelovimab

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We have read with great interest the Correspondence of Daichi Yamasoba and his colleagues,
1
  • Yamasoba D
  • Kosugi Y
  • Kimura I
  • et al.
Sensitivity to neutralization of SARS-CoV-2 omicron subvariants to therapeutic monoclonal antibodies.

which demonstrated the efficacy of all commercially available monoclonal antibodies against dominant omicron subvariants. In this Correspondence, similar to others,

2
  • Cao Y
  • Yisimayi A
  • Jian F
  • et al.
BA.2.12.1, BA.4 and BA.5 evade antibodies caused by Omicron infection.

one monoclonal antibody stands out, namely bebtelovimab. Of all the monoclonal antibodies available, bebtelovimab is the only one to have shown remarkably preserved in vitro activity against all variants of SARS-CoV-2, including the omicron variant and the BA.4 and BA.5 subvariants. more recent which are now becoming dominant.

Bebtelovimab (175 mg strength), which is licensed by Eli Lilly, is a neutralizing immunoglobulin (Ig)-G1 monoclonal antibody targeting the SARS-CoV-2 spike protein. Bebtelovimab received emergency use authorization from the United States Food and Drug Administration in February 2022, for early treatment of mild to moderate COVID-19 in high-risk adults and children over 12 years old. Authorization was based on results from the BLAZE-4 phase 2 trial
3
  • Dougan M
  • Azizad M
  • Chen P
  • et al.
Bebtelovimab, alone or in combination with bamlanivimab and etesevimab, as broadly neutralizing monoclonal antibody treatment for mild to moderate outpatient COVID-19.

and the demonstrated activity of bebtelovimab against omicron subvariants.

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FDA
Coronavirus (COVID-19) Update: FDA clears new monoclonal antibody for treatment of COVID-19 that retains activity against omicron variant.

It should be noted that there are still no phase 3 data available (clinicaltrials.gov NCT04634409).

Despite the critical interest of bebtelovimab as a COVID-19 treatment strategy, as a single intravenous dose administered over 30 sec with no drug interaction, it has not been submitted to regulatory authorities anywhere outside of the United States. United, whether for clinical care or research purposes. However, Eli Lilly has just decided to supply 150,000 additional doses of bebtelovimab to the US government alone.
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Lilly Investors
Lilly will provide 150,000 additional doses of bebtelovimab to the US government as part of an ongoing effort to provide treatment options for COVID-19.

Bebtelovimab would be an important antiviral globally, especially when nirmatrelvir boosted ritonavir, a major oral anti-SARS-CoV-2 drug with retained efficacy against all omicron variants but with many drug interactions , is contraindicated. Remdesivir has proven its effectiveness in early treatment but currently requires 3 days of intravenous administration, which limits its use in outpatient settings. Molnupiravir has not been recommended in international guidelines, or is only recommended when no other treatment options exist due to questions about its efficacy and safety. Other currently commercially available monoclonal antibodies have reduced in vitro activity against novel variants.
1
  • Yamasoba D
  • Kosugi Y
  • Kimura I
  • et al.
Sensitivity to neutralization of SARS-CoV-2 omicron subvariants to therapeutic monoclonal antibodies.

,

2
  • Cao Y
  • Yisimayi A
  • Jian F
  • et al.
BA.2.12.1, BA.4 and BA.5 evade antibodies caused by Omicron infection.

Beneficence is one of the fundamental principles of health care ethics and must be respected by all health actors, including entities that develop therapeutic options. Here, we advocate that bebtelovimab be available outside of the United States for patients worldwide. Bebtelovimab should be evaluated against current predominant variants in independent clinical research, either alone or in combination with other antiviral options, and should be used for clinical care when no other treatment option exists, particularly in immunocompromised populations.

MH has received honoraria for educational events from Gilead and support to attend meetings from Gilead and Pfizer. LP is a member of Pfizer’s Scientific Advisory Board on Antibiotics and receives support to attend meetings from Gilead, Merck and Menarini. AC has received research grants from Merck, AbbVie, Gilead, Viiv Healthcare and meeting support from Gilead. All other authors declare no competing interests.

References

  1. 1.
    • Yamasoba D
    • Kosugi Y
    • Kimura I
    • et al.

    Sensitivity to neutralization of SARS-CoV-2 omicron subvariants to therapeutic monoclonal antibodies.

    Lancet Infect Dis. 2022; 22: 942-943

  2. 2.
    • Cao Y
    • Yisimayi A
    • Jian F
    • et al.

    BA.2.12.1, BA.4 and BA.5 evade antibodies caused by Omicron infection.

    Nature. 2022; ()

  3. 3.
    • Dougan M
    • Azizad M
    • Chen P
    • et al.

    Bebtelovimab, alone or in combination with bamlanivimab and etesevimab, as broadly neutralizing monoclonal antibody treatment for mild to moderate outpatient COVID-19.

    MedRxiv. 2022;

  4. 4.

    Coronavirus (COVID-19) Update: FDA clears new monoclonal antibody for treatment of COVID-19 that retains activity against omicron variant.

  5. 5.

    Lilly will provide 150,000 additional doses of bebtelovimab to the US government as part of an ongoing effort to provide treatment options for COVID-19.

Related Articles

  • Neutralizing sensitivity of SARS-CoV-2 omicron subvariants to therapeutic monoclonal antibodies
    • During the current pandemic, SARS-CoV-2 has diversified considerably. The omicron variant (B.1.1.529) was identified in late November 2021 and quickly spread around the world. As of May 2022, the omicron BA.2 sub-variant is the most dominant variant in the world. Other omicron subvariants have since emerged and some of these have begun to outperform BA.2 in several countries. For example, the omicron BA.2.11 subvariant is spreading in France, and the BA.2.12.1 and BA.4/5 subvariants are becoming dominant in the United States and South Africa, respectively (appendix pp 4– 5).

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