| Background | Concizumab (mAb 2021) is a high-affinity, humanized, monoclonal IgG4 antibody (mAb) developed by Novo Nordisk A/S. It was directed against the Kunitz-2 domain of human tissue factor (TF) pathway inhibitor (TFPI), designed to target and selectively block the factor X (FX) a (FXa) binding site of TFPI. As a mAb, concizumab has the advantage of being administered subcutaneously, and exhibits good solubility and stability, allowing administration as a liquid formulation via a ready- and easy-to-use portable pen device. Phase 2 trials of concizumab are ongoing for Haemophilia A and B. On 12 October 2017, orphan designation (EU/3/17/1940) was granted by the European Commission to Novo Nordisk A/S, Denmark, for concizumab for the treatment of haemophilia B. |
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