CDSCO Panel Approves Pfizer's Protocol Amendment Proposal for Marstacimab
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization CDSCO has approved the Protocol amendment proposal presented by the drug major Pfizer to study Marstacimab in Hemophilia.
This came after the firm presented the details of all ongoing and completed trials conducted on IMP worldwide before the committee.
Marstacimab is in development as a prophylactic treatment to prevent or reduce the frequency of bleeding episodes in individuals with severe haemophilia A or moderately severe to severe haemophilia B with or without inhibitors.
Marstacimab targets TFPI, one of the body's natural mechanisms that inhibit the initiation of blood clotting. By targeting the Kunitz-2 domain of TFPI, marstacimab may help re-establish the balance between bleeding and blood clot formation.
At the recent SEC meeting for Oncology and Hematology held on 30th May 2023, the expert panel reviewed the details of all ongoing and completed trials conducted on IMP worldwide that were presented by the drug major Pfizer.
After detailed deliberation, the committee recommended the grant of approval for the proposed protocol amendment 2 dated 01-Dec-2022, study protocol no. B7841007 as presented.
