On October 11th local time, the US FDA approved Pfizer's drug Hympavzi (marstalimab) for routine prevention or reduction of bleeding in adult and pediatric patients aged 12 and above with hemophilia A and hemophilia B, who do not contain inhibitors of coagulation factors VIII and IX (neutralizing antibodies).
It is reported that this therapy is the first hemophilia B therapy that only requires subcutaneous injection once a week. It can be used to treat hemophilia A and hemophilia B patients by targeting tissue factor pathway inhibitors (TFPI).
This innovative therapy has been granted fast track status by the US FDA. In phase 2 clinical trials, it was able to reduce the annual bleeding rate of participants by over 75%.
It is worth mentioning that this innovative therapy for hemophilia has also been approved for clinical trials in China.