Concizumab, sold under the brand name Alhemo, is a monoclonal antibody used for the treatment of hemophilia B.[5] It is an anti-tissue factor pathway inhibitor.[5]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Tissue factor pathway inhibitor |
| Clinical data | |
| Trade names | Alhemo |
| 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 was approved for medical use in Canada in March 2023.[4][7]
Medical uses
editConcizumab is indicated for the treatment of people with hemophilia B who have factor IX inhibitors and require routine prophylaxis to prevent or reduce the frequency of bleeding episodes.[5][6]
Society and culture
editLegal status
editIn October 2024, the Committee for Medicinal Products for Human Use of the European 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.[8] The applicant for this medicinal product is Novo Nordisk A/S.[8][9]
Names
editConcizumab is the international nonproprietary name.[10]
References
edit- ^ a b "Alhemo APMDS". Therapeutic Goods Administration (TGA). 29 September 2023. Archived from the original on 10 March 2024. Retrieved 7 March 2024.
- ^ "Alhemo (Novo Nordisk Pharmaceuticals Pty Ltd)". Therapeutic Goods Administration (TGA). 28 July 2023. Archived from the original on 10 March 2024. Retrieved 10 September 2023.
- ^ "AusPAR: Alhemo". Therapeutic Goods Administration (TGA). 18 March 2024. Retrieved 31 March 2024.
- ^ a b "Alhemo Product information". Health Canada. 10 March 2023. Archived from the original on 24 March 2023. Retrieved 9 June 2023.
- ^ a b c d "Alhemo (concizumab injection) Product Monograph" (PDF). Health Canada. Archived (PDF) from the original on 3 March 2024. Retrieved 3 March 2024.
- ^ a b "Summary Basis of Decision for Alhemo". Health Canada. 31 May 2023. Archived from the original on 10 March 2024. Retrieved 9 June 2023.
- ^ "Health Canada approves Alhemo, the first subcutaneous prophylactic treatment for people living with hemophilia B with inhibitors" (Press release). Novo Nordisk Canada. 17 April 2023. Archived from the original on 9 June 2023. Retrieved 9 June 2023 – via Newswire.
- ^ a b "Alhemo EPAR". European Medicines Agency (EMA). 17 October 2024. Retrieved 19 October 2024.
- ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024". European Medicines Agency (EMA). 18 October 2024. Retrieved 21 October 2024.
- ^ World Health Organization (2013). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 70". WHO Drug Information. 27 (3). hdl:10665/331167.
