Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2025 Aug;85(8):1049-1054.
doi: 10.1007/s40265-025-02186-w. Epub 2025 Jun 9.

Sipavibart: First Approval

Susan J Keam  1
Affiliations
Review

Sipavibart: First Approval

Susan J Keam. Drugs. 2025 Aug.

Abstract

Sipavibart (KAVIGALE®), a recombinant human immunoglobulin (Ig)G1-based antibody, is being developed by AstraZeneca for the pre-exposure prophylaxis of COVID-19 in immunocompromised individuals. Sipavibart was approved in December 2024 in Japan to prevent the onset of infection caused by SARS-CoV-2 in adults and adolescents aged ≥ 12 years weighing ≥ 40 kg where vaccination against infection caused by SARS-CoV-2 is not recommended or may not achieve a sufficient immune response. Sipavibart was also approved in the EU for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged ≥ 12 years weighing ≥ 40 kg who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments in January 2025 and in Canada in March 2025. This article summarizes the milestones in the development of sipavibart leading to this first approval for the pre-exposure prophylaxis of COVID-19 in immunocompromised adults and adolescents.

PubMed Disclaimer

Conflict of interest statement

Declarations. Funding: The preparation of this review was not supported by any external funding. Authorship and Conflict of interest: During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan J. Keam is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content. Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability: Not applicable.

References

    1. Cai Y, Diallo S, Rosenthal K, et al. AZD3152 neutralizes SARS-CoV-2 historical and contemporary variants and is protective in hamsters and well tolerated in adults. Sci Transl Med. 2024. https://doi.org/10.1126/scitranslmed.ado2817 . - DOI
    1. Planas D, Staropoli I, Planchais C, et al. Escape of SARS-CoV-2 variants KP.1.1, LB.1, and KP3.3 from approved monoclonal antibodies. Pathog Immun. 2024;10(1):1–11.
    1. Haidar G, Thomas S, Loubet P, et al. Efficacy and safety of sipavibart for prevention of COVID-19 in individuals who are immunocompromised (SUPERNOVA): a randomised, controlled, double-blind, phase 3 trial. Lancet Infect Dis. 2025. https://doi.org/10.1016/S1473-3099(24)00804-1 . - DOI
    1. Wang Y, Cao B. The insights from SARS-CoV-2 antibody treatment for future emerging infectious diseases. Lancet Infect Dis. 2024;24(1):2–3.
    1. Focosi D, Casadevall A. Sipavibart: when a success changes into a failure. Lancet Infect Dis. 2025. https://doi.org/10.1016/S1473-3099(24)00812-0 . - DOI

Substances

LinkOut - more resources