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