Denmark-based pharmaceutical company Novo Nordisk (CPH:NOVO-B) announced on Thursday that the US Food and Drug Administration (FDA) has approved Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and paediatric patients 12 years of age and older with haemophilia A or B (HA/HB) without inhibitors.

This expands on the December 2024 approval for HA/HB with inhibitors.

Currently, many treatments for HA/HB 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. By inhibiting TFPI, Alhemo improves the production of thrombin, which helps to clot the blood and prevent bleeding, when clotting factors VIII and IX are missing or deficient regardless of inhibitor status.

Alhemo is provided in prefilled, premixed pens for subcutaneous injection (60 mg/1.5 mL, 150 mg/1.5 mL, or 300 mg/3 mL) via thin 32-gauge, 4mm needles, which are provided separately, offering an additional treatment choice for patients with haemophilia with inhibitors – and now without inhibitors – to further customise their care.