Sipavibart

Last updated

Sipavibart
Monoclonal antibody
Type Whole antibody
Source Human
Target SARS-CoV-2
Clinical data
Trade names Kavigale
Other namesAZD-3152
ATC code
Legal status
Legal status
Identifiers
CAS Number
UNII
KEGG

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]

Contents

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

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

  1. 1 2 3 4 5 6 7 8 9 10 "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.
  2. 1 2 3 4 5 "Kavigale Product information". Union Register of medicinal products. 21 January 2025. Retrieved 2 February 2025.
  3. ↑ "Sipavibart (Code C200075)". NCI Thesaurus. 25 November 2024. Retrieved 16 December 2024.
  4. ↑ 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

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