FDA approved Alhemo® injection as once-daily prophylactic treatment to reduce frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B

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On Dec. 20, 2024, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) had approved Alhemo® (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B with inhibitors, continuing its more than 35-year commitment to those living with rare bleeding disorders.

Alhemo® is a tissue factor pathway inhibitor (TFPI) antagonist that is dosed in a prefilled, premixed pen for subcutaneous injection (60 mg/1.5 mL, 150 mg/1.5 mL, or 300 mg/3 mL) via a thin 32 gauge, 4 mm needle, which is provided separately. Currently, many treatments for hemophilia A or B with inhibitors are administered via intravenous infusions, and Alhemo® is the first subcutaneous injection treatment of its kind for this population.

Alhemo® is designed to block a protein called TFPI in the body that stops blood from clotting. By blocking TFPI, Alhemo® improves the production of thrombin, a protein that helps to clot the blood and prevent bleeding, when the other clotting factors are missing or deficient in the presence of inhibitors.

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Source: Novo Nordisk
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