Chemistry:Emicizumab
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| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Activated factor IX, factor X |
| Clinical data | |
| Trade names | Hemlibra |
| Other names | ACE910, RG6013, emicizumab-kxwh |
| AHFS/Drugs.com | Monograph |
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| Pregnancy category |
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| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| Chemical and physical data | |
| Formula | C6434H9940N1724O2047S45 |
| Molar mass | 145639.02 g·mol−1 |
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).[3] A Phase I clinical trial found that it was well tolerated by healthy subjects.[4]
In November 2017, it was approved in the United States for treatment of haemophilia A in those who had developed resistance to other treatments.[5] 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.[6] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]
Adverse effects
The most common adverse reactions (incidence ≥10%) are injection site reactions, headache, and arthralgia.[8]
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.[3][9]
See also
References
- ↑ 1.0 1.1 "AUSTRALIAN PRODUCT INFORMATION – Hemlibra (Emicizumab)". https://www.guildlink.com.au/gc/ws/ro/pi.cfm?product=rophemli10218.
- ↑ "Summary Basis of Decision (SBD) for Hemlibra". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00411&lang=en.
- ↑ 3.0 3.1 "Neue Wirkstoffe - Emicizumab" (in German). Österreichische Apothekerzeitung (14/2016). 4 July 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. March 2016. doi:10.1182/blood-2015-06-650226. PMID 26626991.
- ↑ "Roche hemophilia drug wins FDA nod, with a warning". Reuters. 2017-11-17. https://www.reuters.com/article/us-roche-hemlibra/roche-hemophilia-drug-wins-fda-nod-with-a-warning-idUSKBN1DG2C4.
- ↑ "FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug". BioPharm International (UBM). 19 April 2018. http://www.biopharminternational.com/fda-grants-roche-breakthrough-therapy-designation-hemophilia-drug.
- ↑ (PDF) New Drug Therapy Approvals 2017 (Report). January 2018. https://www.fda.gov/media/110526/download. Retrieved 16 September 2020.
- ↑ FDA Professional Drug Information
- ↑ "Factor VIII-Mimetic Function of Humanized Bispecific Antibody in Hemophilia A". The New England Journal of Medicine 374 (21): 2044–53. May 2016. doi:10.1056/NEJMoa1511769. PMID 27223146.
External links
- "Emicizumab". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/emicizumab.
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