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Concizumab
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| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Tissue factor pathway inhibitor |
| Clinical data | |
| Trade names | Alhemo |
| Other names | concizumab-mtci |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a625040 |
| 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 can cause thromboembolic events, hypersensitivity, and increased laboratory values of fibrin D dimer and prothrombin fragment 1+2.[12]
Concizumab was approved for medical use in Canada in March 2023,[4] in Australia in July 2023,[1] in the European Union in December 2024,[9] and the United States in December 2024.[8][11]
Medical uses
[edit]Concizumab is indicated 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) with factor VIII inhibitors; or hemophilia B (congenital factor IX deficiency) with factor IX inhibitors.[5][6][7][8][11] In July 2025, the indication was expanded by the US Food and Drug Administration to include the treatment of people with hemophilia A or hemophilia B without inhibitors.[8][13]
History
[edit]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 US Food and Drug Administration (FDA) approved concizumab based on evidence from one clinical trial of 133 participants with hemophilia A with inhibitors (HAwI) and hemophilia B with inhibitors (HBwI).[12] The trial was conducted at 69 sites in a total of 26 countries in North America, Europe, Africa, Asia, and Oceania of which the majority (95%, 126 participants) were from outside the United States.[12] The same trial was used to evaluate the safety of concizumab.[12] The Explorer7 trial (NCT04083781), was a multi-national, multi-center, open-label, phase III trial that investigated the safety and efficacy of concizumab for routine prophylaxis in 91 adults (58 participants with HAwI and 33 participants with HBwI) and 42 adolescents (22 participants with HAwI and 20 participants with HBwI).[12] All participants were prescribed, or were in need of, treatment with bypassing agents.[12]
The FDA granted the application for concizumab priority review, breakthrough therapy, and orphan drug designations.[11]
Society and culture
[edit]Legal status
[edit]Concizumab was approved for medical use in Canada in March 2023,[14] in Australia in July 2023,[1] in the European Union in December 2024,[9] and the United States in December 2024.[15]
In 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.[9] The applicant for this medicinal product is Novo Nordisk A/S.[9][16] Concizumab was authorized for medical use in the European Union in December 2024.[9][10]
Names
[edit]Concizumab is the international nonproprietary name.[17]
Concizumab is sold under the brand name Alhemo.[11]
References
[edit]- ^ a b c d "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.
- ^ a b "Regulatory Decision Summary for Alhemo". Drug and Health Products Portal. 26 July 2023. Retrieved 21 December 2024.
- ^ a b c d e f "Alhemo- concizumab injection, solution". DailyMed. 1 May 2025. Retrieved 24 June 2025.
- ^ a b c d e f "Alhemo EPAR". European Medicines Agency (EMA). 17 October 2024. Retrieved 19 October 2024.
- ^ a b "Alhemo PI". Union Register of medicinal products. 16 December 2024. Retrieved 19 December 2024.
- ^ a b c d e f "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.
- ^ a b c d e f "Drug Trials Snapshot: Alhemo". U.S. Food and Drug Administration. 20 December 2024. Retrieved 2 November 2025. This article incorporates text from this source, which is in the public domain.
- ^ "FDA approves Alhemo as once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B (HA/HB) without inhibitors" (Press release). Novo Nordisk. 31 July 2025. Retrieved 5 August 2025 – via PR Newswire.
- ^ "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.
- ^ "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.
External links
[edit]- Clinical trial number NCT04083781 for "Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (explorer7)" at ClinicalTrials.gov
