CDSCO Approves Novo Nordisk Protocol Amendment Proposal for Concizumab study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by Novo Nordisk to study Concizumab in patients with hemophilia A or B with inhibitors.

This came after Novo Nordisk presented protocol amendment version 11.0 dated 07 October 2024 protocol no. NN7415-4311 (EXPLORER 7). The study was referred to as "Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B with inhibitors."

Concizumab is a monoclonal antibody targeting tissue factor pathway inhibitor (TFPI) for the prophylaxis of bleeding episodes in patients with hemophilia A or B with inhibitors.

It is a hemostatic rebalancing agent that binds to the Kunitz-2 domain of tissue factor pathway inhibitor (TFPI), one of the molecules that contributes to downregulation of coagulation, thereby preventing TFPI from binding to and blocking the factor Xa (FXa) active site.

At the recent SEC meeting for hematology held on January 16, 2025, the expert panel reviewed protocol amendment version 11.0 dated 07 October 2024 protocol no. NN7415-4311 (EXPLORER 7).

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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