FDA Approves Pfizer's Hympavzi for Hemophilia A and B Without Inhibitors

The FDA approval of Pfizer's Hympavzi marks a significant advancement in the treatment of hemophilia A and B for patients without inhibitors, aged 12 and older. Hympavzi, a once-weekly, subcutaneous therapy, stands out as the first non-factor treatment in the U.S. targeting the tissue factor pathway inhibitor, offering a more convenient option compared to traditional infusions[1][2]. The approval is underpinned by robust clinical trial data showing substantial reductions in bleeding rates, with a 92% decrease in those switching from on-demand therapy[3]. While the treatment presents common side effects such as injection site reactions and headaches, it is heralded as a crucial option for reducing the treatment burden for patients[1][3].