Emicizumab

Emicizumab
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
License data	US DailyMed: Emicizumab; US FDA: Emicizumab;
Pregnancy; category	AU: B2; ;
Routes of; administration	Subcutaneous
ATC code	B02BX06 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only); CA: ℞-only / Schedule D; US: WARNINGRx-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, 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]

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]

^ ^a ^b "AUSTRALIAN PRODUCT INFORMATION – Hemlibra (Emicizumab)". Archived from the original on 15 May 2023. Retrieved 8 January 2023.
^ "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.
^ "Summary Basis of Decision (SBD) for Hemlibra". Health Canada. 23 October 2014. Retrieved 29 May 2022.
^ 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.

[Hemlibra_PI-1] "AUSTRALIAN PRODUCT INFORMATION – Hemlibra (Emicizumab)". Archived from the original on 15 May 2023. Retrieved 8 January 2023.

[FDA-AllBoxedWarnings-2] "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.

[3] "Summary Basis of Decision (SBD) for Hemlibra". Health Canada. 23 October 2014. Retrieved 29 May 2022.

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

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

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

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

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