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Concizumab

Medication From Wikipedia, the free encyclopedia

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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]

Quick Facts Monoclonal antibody, Type ...

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]

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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] 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 indicators.[8][14]

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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]

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

Names

Concizumab is the international nonproprietary name.[16]

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

References

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