As with any medicine, the MHRA will keep the safety and effectiveness of concizumab under close review.
Source of the image: UK Government (MHRA) – Original URL
Approval Announcement
From:
Medicines and Healthcare products Regulatory Agency
Published
24 October 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine concizumab (brand name: Alhemo) to prevent or reduce the frequency of bleeding episodes (prophylaxis) in people aged 12 years and older with haemophilia A or B with inhibitors.
What is Haemophilia?
Haemophilia is a rare, inherited condition that affects the way blood clots. People with haemophilia A or B are at higher risk of bleeding because they lack proteins that help the blood clot (clotting factor VIII for haemophilia A and clotting factor IX for haemophilia B).
How Concizumab Works
The active substance, concizumab, which acts independently of factor VIII and factor IX, works by blocking a natural protein that prevents blood from clotting (known as tissue factor pathway inhibitor). By inhibiting this protein, concizumab increases Factor Xa activity, a component in the blood clotting (coagulation) process, allowing the blood to clot more effectively and prevent bleeding in people with haemophilia.
Administration
Concizumab is injected subcutaneously (under the skin) daily.
Side Effects and Reporting
A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), available on the MHRA website within 7 days of approval.
As with any medicine, the MHRA will keep the safety and effectiveness of concizumab under close review.
Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to Editors
- The new marketing authorisation was granted on 6 October 2025 to Novo Nordisk.
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- Concizumab has been approved through the International Recognition Procedure (IRP). The IRP allows the MHRA to take into account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients.
- The MHRA retains the authority to reject applications if the evidence provided is not considered sufficiently robust.
For more information about haemophilia, visit: Haemophilia – NHS
About the MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.