Concizumab

Last updated

Concizumab
Monoclonal antibody
Type Whole antibody
Source Humanized
Target Tissue factor pathway inhibitor
Clinical data
Trade names Alhemo
Other namesconcizumab-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]

Contents

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]

Medical uses

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]

History

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 concizumab priority review, breakthrough therapy, and orphan drug designations. [11]

Society and culture

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] [14] Concizumab was authorized for medical use in the European Union in December 2024. [9] [10]

Names

Concizumab is the international nonproprietary name. [15]

Concizumab is sold under the brand name Alhemo. [11]

References

  1. 1 2 3 "Alhemo APMDS". Therapeutic Goods Administration (TGA). 29 September 2023. Archived from the original on 10 March 2024. Retrieved 7 March 2024.
  2. ↑ "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.
  3. ↑ "AusPAR: Alhemo". Therapeutic Goods Administration (TGA). 18 March 2024. Retrieved 31 March 2024.
  4. 1 2 "Alhemo Product information". Health Canada. 10 March 2023. Archived from the original on 24 March 2023. Retrieved 9 June 2023.
  5. 1 2 3 4 "Alhemo (concizumab injection) Product Monograph" (PDF). Health Canada. Archived (PDF) from the original on 3 March 2024. Retrieved 3 March 2024.
  6. 1 2 "Summary Basis of Decision for Alhemo". Health Canada . 31 May 2023. Archived from the original on 10 March 2024. Retrieved 9 June 2023.
  7. 1 2 "Regulatory Decision Summary for Alhemo". Drug and Health Products Portal. 26 July 2023. Retrieved 21 December 2024.
  8. 1 2 3 4 5 https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761315s000lbl.pdf
  9. 1 2 3 4 5 "Alhemo EPAR". European Medicines Agency (EMA). 17 October 2024. Retrieved 19 October 2024.
  10. 1 2 "Alhemo PI". Union Register of medicinal products. 16 December 2024. Retrieved 19 December 2024.
  11. 1 2 3 4 5 6 "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. Retrieved 21 December 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  12. ↑ "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.
  13. ↑ 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.
  14. ↑ "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.
  15. ↑ World Health Organization (2013). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 70". WHO Drug Information. 27 (3). hdl: 10665/331167 .
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.