The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved concizumab, marketed as Alhemo, for the prevention or reduction of bleeding episodes in people aged 12 years and older with haemophilia A or B with inhibitors.
The marketing authorisation, granted on 6 October 2025, allows the use of the therapy developed by Novo Nordisk for routine prophylaxis in eligible patients.
Haemophilia is a rare inherited disorder that impairs the blood’s ability to clot. Individuals with haemophilia A lack clotting factor VIII, while those with haemophilia B lack factor IX, resulting in an increased risk of prolonged or spontaneous bleeding.
Concizumab, a monoclonal antibody, works independently of factor VIII and IX. It targets and blocks tissue factor pathway inhibitor (TFPI), a natural protein that limits blood clot formation. By inhibiting TFPI, the medicine increases the activity of Factor Xa, enhancing the blood’s ability to clot and thereby reducing bleeding risk. The treatment is administered as a once-daily subcutaneous injection.
Concizumab was authorised under the International Recognition Procedure (IRP), which allows the MHRA to consider assessments made by trusted international regulators while retaining final approval authority in the UK.
The MHRA said it will continue to monitor the safety and effectiveness of concizumab through its routine pharmacovigilance systems. Patients and healthcare professionals are encouraged to report any suspected side effects via the Yellow Card scheme at yellowcard.mhra.gov.uk.
Detailed product information, including potential side effects, will be available in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) on the MHRA website within seven days of approval.
The MHRA, an executive agency of the Department of Health and Social Care, oversees the regulation of medicines and medical devices in the UK, ensuring that the benefits of approved products outweigh their risks.
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