 | |
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Activatedfactor IX,factor X |
| Clinical data | |
| Trade names | Hemlibra |
| Other names | ACE910, RG6013, emicizumab-kxwh |
| AHFS/Drugs.com | Monograph |
| 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 nameHemlibra, is a humanizedbispecific monoclonal antibody for the treatment ofhaemophilia A, developed byGenentech andChugai (both organizations are subsidiaries ofHoffmann-La Roche).[4] A Phase Iclinical 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 thebreakthrough therapy designation for treatment of haemophila A in those who havenot developed resistance to other treatments.[7] The U.S.Food and Drug Administration (FDA) considers it to be afirst-in-class medication.[8]
Studies indicate that emicizumab is a better therapy compared to the previous generations, due to subcutaneous administration and fewer injections, which reduces injection site reactions and makes therapy less troublesome.[9]
The most common adverse reactions (incidence ≥10%) areinjection site reactions,headache, andarthralgia.[10]
Emicizumab binds to both the activatedcoagulation factor IX and tofactor X, mediating the activation of the latter. This is normally the function ofcoagulation factor VIII, which is missing in haemophilia A patients.[4][11]
