CDSCO Approves Novo Nordisk Protocol Amendment Proposal for Concizumab study

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-02-07T18:00:33+05:30 | Updated On 7 Feb 2025 6:00 PM IST

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.

Also Read: Sanofi Healthcare India gets CDSCO Panel nod to study Nirsevimab

concizumabcdscoNovo Nordiskprotocol amendmentHemophilia

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751