CDSCO Panel Approves Novo Nordisk Protocol Amendment Proposal for Concizumab
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novo Nordisk protocol amendment proposal for the clinical trial titled, “Efficacy and safety of Concizumab prophylaxis in patients with haemophilia A or B without inhibitors”.
This came after the drug major Novo Nordisk presented protocol amendment version 6.0 dated 22 June 2023 protocol No. NN7415-4307.
The purpose of the aforementioned study is to examine the effects of concizumab on the body in individuals having haemophilia without inhibitors.
Concizumab has been used in trials studying the treatment of Haemophilia A and Congenital Bleeding Disorder. Concizumab enhances thrombin generation (TG) potential in haemophilia patients by inhibiting tissue factor pathway inhibitors (TFPI).
When the TFPI inhibitory activity is decreased, sufficient FXa is produced by the FVIIa-tissue factor complex to achieve hemostasis. Based on this mechanism of action, concizumab is expected to be equally effective in haemophilia A and B, regardless of inhibitor status.
At the recent SEC meeting for Oncology and Hematology held on 21st and 22nd December 2023, the expert panel reviewed the proposal protocol amendment version 6. dated 22 June 2023 protocol No. NN7415-4307.
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
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