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 |
| MedlinePlus | a622046 |
| License data |
|
| Pregnancy category |
|
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| 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 (both organizations are subsidiaries of Hoffmann-La Roche).[4] Emicizumab is a bispecific factor IXa- and factor X-directed antibody.[3]
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 the 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]
- ^ a b "AUSTRALIAN PRODUCT INFORMATION – Hemlibra (Emicizumab)". Archived from the original on 15 May 2023. Retrieved 8 January 2023.
- ^ "Summary Basis of Decision (SBD) for Hemlibra". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ a b "Hemlibra- emicizumab injection, solution". DailyMed. 28 October 2024. Retrieved 11 July 2025.
- ^ Spreitzer H (4 July 2016). "Neue Wirkstoffe - Emicizumab". Österreichische Apothekerzeitung (in German) (14/2016).
- ^ "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. U.S. Food and Drug Administration (FDA) (Report). January 2018. Archived from the original (PDF) on 14 September 2019. Retrieved 16 September 2020.