Concizumab
| 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 name Alhemo, is a monoclonal antibody used for the treatment of hemophilia A and hemophilia 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]
- ^ a b c "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 "Alhemo (concizumab injection) Product Monograph" (PDF). Health Canada. Archived (PDF) from the original on 3 March 2024. Retrieved 3 March 2024.
- ^ "Summary Basis of Decision for Alhemo". Health Canada. 31 May 2023. Archived from the original on 10 March 2024. Retrieved 9 June 2023.
- ^ "Regulatory Decision Summary for Alhemo". Drug and Health Products Portal. 26 July 2023. Retrieved 21 December 2024.
- ^ a b c d "Alhemo- concizumab injection, solution". DailyMed. 1 May 2025. Retrieved 24 June 2025.
- ^ a b Cite error: The named reference
Alhemo EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Alhemo PIwas invoked but never defined (see the help page). - ^ a b "FDA approves drug to prevent or reduce the frequency of bleeding episodes for patients with hemophilia A with inhibitors or hemophilia B with inhibitors". U.S. Food and Drug Administration (FDA). 20 December 2024. Archived from the original on 21 December 2024. Retrieved 21 December 2024. This article incorporates text from this source, which is in the public domain.
- ^ "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.
- ^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.