Emicizumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Activated factor IX, factor X |
| Clinical data | |
| Trade names | Hemlibra |
| Other names | ACE910 |
| Routes of administration | Subcutaneous injection |
| ATC code | |
| Legal status | |
| Legal status | |
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Emicizumab (trade name Hemlibra) is a humanized monoclonal antibody for the treatment of haemophilia A, developed by Chugai (a subsidiary of Roche).[2] A Phase I clinical trial found that it was well tolerated by healthy subjects.[3]
In November 2017, it was approved by the US FDA for treatment of haemophilia A patients who had developed resistance to other treatments.[4] It was subsequently approved by the US FDA in April 2018 under the breakthrough therapy designation for treatment of haemophila A patients who have not developed resistance to other treatments.[5]
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.[2][6]
References
- ^ "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 Oct 2023.
- ^ a b H. Spreitzer (4 July 2016). "Neue Wirkstoffe - Emicizumab". Österreichische Apothekerzeitung (in German) (14/2016).
- ^ Uchida, N; Sambe, T; Yoneyama, K; Fukazawa, N; Kawanishi, T; Kobayashi, S; Shima, M (2016). "A first-in-human phase 1 study of ACE910, a novel factor VIII–mimetic bispecific antibody, in healthy subjects". Blood. 127 (13): 1633–1641. doi:10.1182/blood-2015-06-650226. PMC 4817308. PMID 26626991.
- ^ "Roche hemophilia drug wins FDA nod, with a warning". Reuters. 2017-11-17.
- ^ "FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug". BioPharm International. UBM. 19 April 2018. Retrieved 2018-04-20.
- ^ Shima, M; Hanabusa, H; Taki, M; Matsushita, T; Sato, T; Fukutake, K; Fukazawa, N; Yoneyama, K; Yoshida, H; Nogami, K (2016). "Factor VIII-Mimetic Function of Humanized Bispecific Antibody in Hemophilia A". New England Journal of Medicine. 374 (21): 2044–53. doi:10.1056/NEJMoa1511769. PMID 27223146.
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