Alhemo
Authorised
This medicine is authorised for use in the European Union
concizumab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Alhemo is a medicine used to prevent bleeding episodes (routine prophylaxis) in patients with haemophilia A or B aged 12 years and above.
Haemophilia A and B are inherited bleeding disorders caused by the lack of factor VIII (for haemophilia A) or factor IX (for haemophilia B), which are proteins needed to produce blood clots to stop bleeding.
Alhemo is used in people who have developed inhibitors, which are antibodies (proteins made by the body’s natural defences) in the blood that act against factor VIII or factor IX medicines and prevent them from working properly.
Alhemo contains the active substance concizumab.
The medicine can only be obtained with a prescription. Treatment should be started under the supervision of a doctor experienced in the treatment of haemophilia or bleeding disorders.
Alhemo is given as an injection under the skin once a day, using a pre-filled pen. Treatment begins with a starting dose based on the patient’s bodyweight for the first day. A lower dose is given from the second day. After 4 weeks of treatment, the doctor will adjust the dose based on blood levels of concizumab. Patients can inject themselves if they have been trained appropriately.
For more information about using Alhemo, see the package leaflet or contact your doctor or pharmacist.
Patients with haemophilia A lack factor VIII, and patients with haemophilia B lack factor IX, which are proteins in the body that help the blood to clot. In patients who have developed inhibitors, medicines that contain factor VIII or factor IX do not work properly. However, the body has another protein that also helps the blood to clot, which is called factor Xa. Normally, this factor is quickly blocked by tissue factor pathway inhibitor (TFPI), the protein that prevents factor Xa from clotting.
The active substance of Alhemo, concizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to TFPI. By attaching to TFPI, concizumab prevents TFPI from blocking factor Xa, which increases blood clotting by factor Xa in patients with haemophilia A or B.
A main study in 127 men and boys, aged 12 years or older, with haemophilia A or B with inhibitors found that Alhemo is more effective at reducing the number of bleeding episodes. Among the 33 patients included in the analysis of yearly number of bleedings, who received preventive treatment with Alhemo, the yearly number of bleedings decreased to 1.7, compared with 11.8 bleeding episodes in patients who did not receive preventive treatment (but instead on demand treatment with intravenous replacement with factor-containing products).
Patients receiving Alhemo also had a slight improvement in pain and physical functioning based on a standardised scoring system (called SF-36v2). Among patients who received preventive treatment with Alhemo, the pain and physical functioning scores improved by 9.2 and 4.5 points on the 100-point scale, compared with 2.2 and 1.2 points respectively, in patients who did not receive preventive treatment.
For the full list of side effects and restrictions with Alhemo, see the package leaflet.
The most common side effects with Alhemo (which may affect more than 1 in 10 people) include reactions at the injection site. Some side effects can be serious. The most common include thromboembolic events (problems due to the formation of blood clots in the blood vessels) (0.9%) and hypersensitivity (allergic reactions) (0.3%).
At the time of approval, most treatments for patients with haemophilia A or B involved infusions (drips) into a vein of factor VIII or IX as replacement therapy. Although new treatments have been authorised for haemophilia A and B in people without inhibitors, treatment options are limited for those with inhibitors. Alhemo was shown to be effective at preventing bleeding episodes in patients with haemophilia A or B with inhibitors and improving patient’s quality of life. In terms of side effects, Alhemo is generally well tolerated. The main safety issue is the risk of thromboembolic events which was considered manageable.
The European Medicines Agency therefore decided that Alhemo’s benefits are greater than its risks and that it can be authorised for use in the EU.
The company that markets Alhemo will provide educational materials for healthcare professionals expected to use the medicine with information on its safety, including the potential risk of thromboembolic events and the need to monitor patients for signs and symptoms. Patients will also receive a guide as well as a card that they should carry with them.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alhemo have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Alhemo are continuously monitored. Suspected side effects reported with Alhemo are carefully evaluated and any necessary action taken to protect patients.
Alhemo received a marketing authorisation valid throughout the EU on 13 December 2024.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Alhemo
- Active substance
- concizumab
- International non-proprietary name (INN) or common name
- concizumab
- Therapeutic area (MeSH)
- Hemophilia A
- Hemophilia B
- Anatomical therapeutic chemical (ATC) code
- B02BX10
Pharmacotherapeutic group
AntihemorrhagicsTherapeutic indication
Alhemo is indicated for routine prophylaxis of bleeding in patients with:
- haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and of 12 years of age or more.
- haemophilia B (congenital factor IX deficiency) with FIX inhibitors and of 12 years of age or more.
News on Alhemo
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