Pfizer Gets CDSCO Panel Nod To study Marstacimab
Pfizer
New Delhi: The pharmaceutical major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase 1b clinical study of Marstacimab as per the amendment presented by the firm.
This came after the firm presented Phase 1b clinical study protocol no. B7841014 amendment 1, dated 02 December 2024.
Marstacimab (PF-06741086) is a monoclonal antibody medication used as routine prophylaxis to prevent or reduce bleeding episodes in adults and adolescents with hemophilia A or B without inhibitors. It works by targeting the tissue factor pathway inhibitor (TFPI), a protein that naturally limits blood clot formation.
Marstacimab is a human monoclonal IgG1 antibody directed against the K2 to neutralize TFPI. Even in the absence of FVIII or FIX, marstacimab-induced inhibition of TFPI leads to increased generation of FXa and, ultimately, thrombin production and clot formation.
At the recent SEC meeting for Hematology held on 6th March 2025, the expert panel reviewed the Phase 1b clinical study protocol no. B7841014 Amendment 1 dated 02 December2024.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm
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