Emicizumab-kxwh

Emicizumab

Emicizumab

Monoclonal antibody

Emicizumab, sold under the brand name Hemlibra, is a humanized bispecific monoclonal antibody for the treatment of haemophilia A, developed by Genentech and Chugai (a subsidiary of Hoffmann-La Roche).[4] A Phase I clinical trial found that it was well tolerated by healthy subjects.[5]

Quick Facts Monoclonal antibody, Type ...

In November 2017, it was approved in the United States for treatment of haemophilia A in those who had developed resistance to other treatments.[6] It was subsequently approved by the US FDA in April 2018 under the breakthrough therapy designation for treatment of haemophila A in those who have not developed resistance to other treatments.[7] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[8]

Adverse effects

The most common adverse reactions (incidence ≥10%) are injection site reactions, headache, and arthralgia.[9]

Mechanism of action

Emicizumab binds to both the activated coagulation factor IX and to factor X, mediating the activation of the latter. This is normally the function of coagulation factor VIII, which is missing in haemophilia A patients.[4][10]

See also

References

  1. [1]
    "AUSTRALIAN PRODUCT INFORMATION – Hemlibra (Emicizumab)". Archived from the original on 15 May 2023. Retrieved 8 January 2023.
  2. [2]
    "Summary Basis of Decision (SBD) for Hemlibra". Health Canada. 23 October 2014. Retrieved 29 May 2022.
  3. [3]
    "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  4. [4]
    Spreitzer H (4 July 2016). "Neue Wirkstoffe - Emicizumab". Österreichische Apothekerzeitung (in German) (14/2016).
  5. [5]
    Uchida N, Sambe T, Yoneyama K, Fukazawa N, Kawanishi T, Kobayashi S, Shima M (March 2016). "A first-in-human phase 1 study of ACE910, a novel factor VIII-mimetic bispecific antibody, in healthy subjects". Blood. 127 (13): 1633–41. doi:10.1182/blood-2015-06-650226. PMC 4817308. PMID 26626991.
  6. [6]
    "Roche hemophilia drug wins FDA nod, with a warning". Reuters. 17 November 2017.
  7. [7]
    "FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug". BioPharm International. UBM. 19 April 2018. Retrieved 20 April 2018.
  8. [8]
    New Drug Therapy Approvals 2017 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2018. Retrieved 16 September 2020.
  9. [9]
    FDA Professional Drug Information
  10. [10]
    Shima M, Hanabusa H, Taki M, Matsushita T, Sato T, Fukutake K, et al. (May 2016). "Factor VIII-Mimetic Function of Humanized Bispecific Antibody in Hemophilia A". The New England Journal of Medicine. 374 (21): 2044–53. doi:10.1056/NEJMoa1511769. PMID 27223146.
  • "Emicizumab". Drug Information Portal. U.S. National Library of Medicine.


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