The China Center for Drug Evaluation (CDE) has accepted for review a market approval filing for Pfizer Inc.’s (NYSE: PFE) Category 1 biologic drug marstacimab (PF-06741086), according to the agency’s website. This regulatory milestone in China follows similar submissions to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in December 2023, aiming to secure approvals for treating hemophilia A and B patients without inhibitors to Factor VIII (FVIII) or Factor IX (FIX).
Marstacimab, a tissue factor pathway inhibitor (TFPI), is designed to target the Kunitz 2 domain of the TFP, a natural anticoagulant that helps in preventing blood clot formation. Data from the Phase III BASIS study demonstrated that marstacimab injections significantly reduced the annualized bleeding rate (ABR) by 91.6% compared to on-demand treatment and by 35.2% compared to prophylactic treatment. Moreover, the weekly subcutaneous injections have been shown to markedly enhance the health-related quality of life for patients. Pfizer is poised to potentially offer the first once-weekly subcutaneous treatment for hemophilia B and a flat-dose treatment option for individuals with hemophilia A or B. The U.S. FDA’s PDUFA date for marstacimab is anticipated in the fourth quarter of 2024, with the EMA’s decision expected in the first quarter of 2025.- Flcube.com
