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.
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).
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.
Concizumab is injected subcutaneously (under the skin)
daily.
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
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The new marketing authorisation was granted on 6 October 2025
to Novo Nordisk.
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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.
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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.
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For more information about haemophilia, visit: Haemophilia -
NHS
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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.
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The MHRA is an executive agency of the Department of Health
and Social Care.
