Novo Nordisk's Alhemo Wins FDA Nod, Expanding Subcutaneous Option For Hemophilia Patients

The U.S. Food and Drug Administration approved on Friday, the Novo Nordisk A/S (NYSE:NVO) Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in patients 12 years of age and older with hemophilia A or B without inhibitors.

In December 2024, the FDA approved Alhemo for patients 12 years of age and older with hemophilia A or B with inhibitors.

Currently, many hemophilia A or B treatments without inhibitors are administered via intravenous infusions. With this approval, Alhemo now offers a subcutaneous injection treatment option for this population.

Alhemo is designed to block a protein called tissue factor pathway inhibitor (TFPI), which stops blood from clotting.

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By inhibiting TFPI, Alhemo improves the production of thrombin, which helps to clot the blood and prevent bleeding, when clotting ...