Chemistry:Sipavibart
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][2]
Sipavibart was authorized for medical use in the European Union in January 2025.[1][3]
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][3]
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][3]
Names
Sipavibart is the international nonproprietary name.[4]
Sipavibart is sold under the brand name Kavigale.[1][3]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 "Kavigale EPAR". 12 December 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/kavigale. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Sipavibart (Code C200075)". 25 November 2024. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C200075.
- ↑ 3.0 3.1 3.2 3.3 "Kavigale Product information". 21 January 2025. https://ec.europa.eu/health/documents/community-register/html/h1900.htm.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 91". WHO Drug Information 38 (1). 2024.
Further reading
- "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). December 2024. doi:10.1080/21645515.2024.2387221. PMID 39143811.
- "Escape of SARS-CoV-2 Variants KP.1.1, LB.1, and KP3.3 From Approved Monoclonal Antibodies". Pathogens & Immunity 10 (1): 1–11. 2024. doi:10.20411/pai.v10i1.752. PMID 39391808.
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