Concizumab: First Approval

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan J. Keam is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable

Additional information about this Adis Drug Review can be found here.

Abstract 

Concizumab (Alhemo™),  a subcutaneously administered humanised monoclonal IgG4 antibody against tissue factor pathway inhibitor (TFPI), binds to the Kunitz-2 domain of TFPI and prevents TFPI from binding to activated Factor X. Concizumab is being developed by Novo Nordisk for the treatment of hemophilia A and B with and without inhibitors. In March 2023, concizumab was approved in Canada for the treatment of adolescent and adult patients (12 years of age or older) with hemophilia B who have FIX inhibitors and require routine prophylaxis to prevent or reduce the frequency of bleeding episodes. This article summarizes the milestones in the development of concizumab leading to this first approval for the treatment of hemophilia B.

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