CDSCO Panel grants Novo Nordisk Protocol Amendment Proposal to study concizumab
New Delhi: Recommending to increase the number of subjects from 15 to 35, 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 the efficacy, safety, and pharmacokinetics of concizumab prophylaxis in children below 12 years with hemophilia A or B with or without inhibitors.
This came after the firm presented protocol amendment version 2.0 dated 06 October 2023 protocol no. NN7415-4616 and increased the number of subjects from India.
This is an open-label study investigating the efficacy, safety, and pharmacokinetics of concizumab prophylaxis in children below 12 years with hemophilia A or B with or without inhibitors.
The nod is subject to the condition that patients less than 3 years old shall not be enrolled in the study and the informed consent form and patient information sheet should comply with the above condition no. 1.
Concizumab is a monoclonal antibody used to treat hemophilia A and B. Concizumab binds to tissue factor pathway inhibitor (TFPI), which prevents TFPI from blocking factor Xa (FXa). This increases FXa activity, which prolongs the coagulation initiation phase and allows for enough thrombin generation to achieve hemostasis. Concizumab is administered subcutaneously as a once-daily prophylactic treatment. It's effective in preventing most spontaneous bleeding and many minor trauma-induced bleeds, but it's unlikely to prevent bleeding in major trauma or surgery settings.
At the SEC meeting for the meeting for hematology held on October 9, 2024, the expert panel reviewed the protocol amendment version 2.0 dated 06 October 2023 protocol no. NN7415-4616.
After detailed deliberation, the committee recommended the approval of the protocol amendment and increasing the number of subjects from 15 to 35 with the following conditions:
1. Patients less than 3 years old shall not be enrolled in the study.
2. The informed consent form and patient information sheet should comply with the above condition no. 1 and the same should be approved by CDSCO.
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