3 Dosing Options: Novo Nordisk FREHEMGO Wins EU Approval

Novo Nordisk has secured European Union (EU) approval for FREHEMGO (denecimig), introducing three dosing options for people living with haemophilia A.

The treatment offers a new approach to routine bleeding prevention, allowing adults and children to choose between monthly, fortnightly and weekly injections.

This flexibility could help patients manage long-term treatment with fewer administration days while maintaining bleeding control.

The European Commission's decision covers patients with and without factor VIII inhibitors, expanding the treatment's potential role across different haemophilia A patient groups.

Three Dosing Options Expand Treatment Flexibility

The European Commission approved FREHEMGO for routine prevention of bleeding episodes in adults and children with haemophilia A. The decision follows the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommendation in September 2026.

• Haemophilia A is an inherited bleeding disorder caused by missing or defective clotting factor VIII.
• Patients can choose once-monthly, once-every-two-weeks or once-weekly dosing.
• The treatment uses a factor VIIIa mimetic bispecific antibody that connects clotting factors IXa and X to support blood clot formation.
• Patients administer the medicine under the skin using a single-use pre-filled pen.

These options give healthcare professionals greater scope to match treatment schedules with individual patient needs and daily routines. For people requiring lifelong bleeding prevention, fewer injection days could also ease the practical burden of treatment.

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FRONTIER Trials Demonstrate Bleeding Prevention Benefits

The FRONTIER clinical program provides the clinical evidence supporting the treatment's EU authorization.

• In FRONTIER2, denecimig significantly reduced annualized bleeding rates compared with patients' previous clotting factor prophylaxis and on-demand treatments.
• FRONTIER3 showed consistent efficacy in children below 12 years compared with adolescents and adults.
• Across the program, a substantial proportion of participants experienced zero treated bleeding episodes.

These findings highlight the potential of FREHEMGO to support long-term bleeding prevention across different age groups. Novo Nordisk plans to introduce the treatment in its first European markets over the coming year. The launch could strengthen the company's haemophilia portfolio while giving patients more flexibility in managing a lifelong condition.