Emicizumab

Emicizumab
Monoclonal antibody
Type	Whole antibody
Source	Humanized
Target	Activated factor IX, factor X
Clinical data
Trade names	Hemlibra
Other names	ACE910, emicizumab-kxwh
AHFS/Drugs.com	Monograph
Pregnancy; category	AU: B2;
Routes of; administration	Subcutaneous
ATC code	B02BX06 (WHO) ;
Legal status
Legal status	US: ℞-only ; EU: Rx-only ; In general: ℞ (Prescription only);
Identifiers
CAS Number	1610943-06-0;
DrugBank	DB13923;
ChemSpider	none;
UNII	7NL2E3F6K3;
KEGG	D10821 ;
Chemical and physical data
Formula	C6434H9940N1724O2047S45
Molar mass	145639.02 g·mol−1

Emicizumab (trade name Hemlibra) is a humanized bispecific antibody for the treatment of haemophilia A, developed by Chugai (a subsidiary of Roche).[1] A Phase I clinical trial found that it was well tolerated by healthy subjects.[2]

In November 2017, it was approved in the United States for treatment of haemophilia A in those who had developed resistance to other treatments.[3] 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.[4] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[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.[1][6]

References

Spreitzer H (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 (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.
"Roche hemophilia drug wins FDA nod, with a warning". Reuters. 17 November 2017.
"FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug". BioPharm International. UBM. 19 April 2018. Retrieved 20 April 2018.
New Drug Therapy Approvals 2017 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2018. Retrieved 16 September 2020.
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.

External links

"Emicizumab". Drug Information Portal. U.S. National Library of Medicine.

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[Spreitzer-1] Spreitzer H (4 July 2016). "Neue Wirkstoffe - Emicizumab". Österreichische Apothekerzeitung (in German) (14/2016).

[2] 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.

[3] "Roche hemophilia drug wins FDA nod, with a warning". Reuters. 17 November 2017.

[4] "FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug". BioPharm International. UBM. 19 April 2018. Retrieved 20 April 2018.

[5] New Drug Therapy Approvals 2017 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2018. Retrieved 16 September 2020.

[6] 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.