| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Tissue factor pathway inhibitor |
| Clinical data | |
| Trade names | Alhemo |
| Other names | concizumab-mtci |
| License data | |
| Pregnancy category | |
| Routes of administration | Subcutaneous |
| Drug class | Antihemorrhagic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6462H10004N1712O2046S46 |
| Molar mass | 145887.81 g·mol−1 |
Concizumab, sold under the brand nameAlhemo, is amonoclonal antibody used for the treatment ofhemophilia A andhemophilia B.[5][8] It is an anti-tissue factor pathway inhibitor.[5][8]
The most common adverse reactions include injection site reactions and hives (urticaria).[11]
Concizumab was approved for medical use in Canada in March 2023,[4][12] in Australia in July 2023,[1] in the European Union in December 2024,[9] and the United States in December 2024.[8][11][13]
Concizumab isindicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people aged twelve years of age and older with hemophilia A (congenital factor VIII deficiency) withfactor VIII inhibitors; or hemophilia B (congenital factor IX deficiency) withfactor IX inhibitors.[5][6][7][8][11]
The efficacy and safety of concizumab were evaluated in a multi-national, multi-center, open-label, phase III trial (NCT04083781) with 91 adult and 42 adolescent male participants with hemophilia A or B with inhibitors who have been prescribed, or are in need of, treatment with therapies that bypass the inhibitor effect.[11]
The FDA granted the application for concizumabpriority review,breakthrough therapy, andorphan drug designations.[11]
In October 2024, theCommittee for Medicinal Products for Human Use of theEuropean Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Alhemo, intended for the prevention of bleeding in people with hemophilia A and FVIII inhibitors or hemophilia B and FIX inhibitors.[9] The applicant for this medicinal product is Novo Nordisk A/S.[9][14] Concizumab was authorized for medical use in the European Union in December 2024.[9][10]
Concizumab is theinternational nonproprietary name.[15]
Concizumab is sold under the brand name Alhemo.[11]
This article incorporates text from this source, which is in thepublic domain.
