CDSCO Panel Approves Pfizer's Proposal for protocol amendment of Marstacimab
New Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) for the protocol amendment of Marstacimab.
This came after the drug major Pfizer presented Protocol Amendment 1 dated 22March 2023, Protocol no. B7841008.
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (marstacimab) for the potential treatment of hemophilia in pediatric patients.
Marstacimab is a human Monoclonal Antibody Directed Against Tissue Factor Pathway Inhibitor currently being developed by Pfizer for the treatment of hemophilia A and hemophilia B.
Marstacimab (PF-06741086) is a human monoclonal immunoglobulin G isotype, subclass 1 (IgG1) that targets the Kunitz 2 domain of tissue factor pathway inhibitor (TFPI), a natural anticoagulation protein that functions to prevent the formation of blood clots. Marstacimab is in development as a prophylactic treatment to prevent or reduce the frequency of bleeding episodes in individuals with severe hemophilia A or moderately severe to severe hemophilia B with or without inhibitors.
At the recent SEC meeting for Oncology and Hematology held on 29th and 30th November 2023, the expert panel reviewed the protocol amendment 1 dated 22 March 2023, Protocol no. B7841008.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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