Sipavibart, sold under the brand name Kavigale, is a medication used for the prevention of COVID-19 in people who are immunocompromised.[1] Sipavibart is a recombinant human IgG1 monoclonal antibody that provides passive immunization against SARS-CoV-2 by binding its spike protein receptor binding domain.[1][3]
Sipavibart was authorized for medical use in the European Union in January 2025.[1][2]
Medical uses
Sipavibart is indicated for the pre-exposure prophylaxis of COVID-19 in people aged twelve years of age and older weighing at least 40 kilograms (88 lb) and who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments.[1][2]
Society and culture
Legal status
In December 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kavigale, intended for the prevention of COVID-19 in immunocompromised people aged twelve years of age and older.[1] Kavigale was reviewed under the EMA's accelerated assessment program.[1] The applicant for this medicinal product is AstraZeneca AB.[1] Sipavibart was authorized for medical use in the European Union in January 2025.[1][2]
Names
Sipavibart is the international nonproprietary name.[4]
Sipavibart is sold under the brand name Kavigale.[1][2]
References
- ^ a b c d e f g h i j "Kavigale EPAR". European Medicines Agency (EMA). 12 December 2024. Retrieved 15 December 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b c d e "Kavigale Product information". Union Register of medicinal products. 21 January 2025. Retrieved 2 February 2025.
- ^ "Sipavibart (Code C200075)". NCI Thesaurus. 25 November 2024. Retrieved 16 December 2024.
- ^ World Health Organization (2024). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 91". WHO Drug Information. 38 (1). hdl:10665/378096.
Further reading
- Loubet P, Gaborit B, Salpin M, Gardeney H, Benotmane I, Systchenko T (December 2024). "Characteristics of the first immunocompromised patients to receive sipavibart as an early access treatment for COVID-19 pre-exposure prophylaxis in France". Human Vaccines & Immunotherapeutics. 20 (1): 2387221. doi:10.1080/21645515.2024.2387221. PMC 11328879. PMID 39143811.
- Planas D, Staropoli I, Planchais C, Yab E, Jeyarajah B, Rahou Y, et al. (2024). "Escape of SARS-CoV-2 Variants KP.1.1, LB.1, and KP3.3 From Approved Monoclonal Antibodies". Pathogens & Immunity. 10 (1): 1–11. doi:10.20411/pai.v10i1.752. PMC 11464000. PMID 39391808.
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