Novo Nordisk's TFPI Antibody Alhemo Receives FDA Approval for Hemophilia A and B

▎Armstrong

On December 20, 2024, Novo Nordisk's TFPI antibody received FDA approval for marketing to treat hemophilia A or B in individuals aged 12 and above. The product is named Alhemo, making it the second TFPI antibody globally.

On October 11, two months ago, Pfizer announced that the TFPI antibody Marstacimab had received FDA approval for marketing to treat hemophilia A and B, under the trade name Hympavz. Concizumab from Novo Nordisk was once the fastest progressing TFPI antibody,But due to thrombotic events, the Phase III clinical trial was once suspended, and it was overtaken by Pfizer's Marstacimab.

Summary

In China, Alphamab Oncology's KN057 is the first TFPI antibody, currently in phase III clinical trials, while Antengene's AP017 is the second TFPI antibody produced in China, currently in phase I clinical trials. The treatment of hemophilia mainly involves coagulation factor replacement therapy and FIX/FX bispecific antibodies. The success of TFPI antibodies provides a new treatment option for hemophilia patients.