Veyvondi
Authorised
This medicine is authorised for use in the European Union
vonicog alfa
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Veyvondi is a medicine used to control bleeding in adults with von Willebrand disease (an inherited bleeding disorder) who cannot be treated with desmopressin (another medicine to stop bleedings) or in whom desmopressin does not work.
It is used to prevent and treat bleeding episodes, including during surgery.
Veyvondi contains the active substance vonicog alfa.
Veyvondi can only be obtained with a prescription and treatment should be supervised by a doctor experienced in treating patients with bleeding disorders.
Veyvondi is given as an injection into a vein. The dose and frequency of the injections depend on whether Veyvondi is used during surgery or to treat or prevent bleeding episodes.
For more information about using Veyvondi, see the package leaflet or contact your doctor or pharmacist.
Patients with von Willebrand disease lack von Willebrand factor, a protein needed for normal clotting of the blood, and as a result, they bleed readily. The active substance in Veyvondi, vonicog alfa, is produced in the laboratory and works in the same way as natural von Willebrand factor. It replaces the missing protein, thereby helping the blood to clot and allowing the bleeding to be controlled.
Veyvondi has been shown to be effective at controlling bleeding episodes in three main studies in adults with von Willebrand disease. Veyvondi was not compared with any other treatments in these studies.
The first study involved 37 patients who were given Veyvondi for the treatment of bleeding episodes. The main measure of effectiveness was based on an assessment of how well the treatment worked. Treatment with Veyvondi was successful in 95% of patients (20 out of 22). A total of 193 bleeding episodes were recorded, and Veyvondi was rated ‘excellent’ or ‘good’ at treating around 98% of bleedings.
The second study involved 15 patients who were given Veyvondi to prevent bleeding during surgery, including major surgery such as knee replacement. In the 15 major and minor surgeries that occurred during the study, Veyvondi was rated as excellent or good at preventing bleeding episodes for all 15 surgeries.
A third study was carried out in 23 patients with severe von Willebrand disease who received Veyvondi as a preventive treatment to avoid bleeding episodes. Before the study, patients had either been using von Willebrand factor treatment on demand and had experienced at least 3 spontaneous bleeds requiring treatment in the last year, or they had been using a plasma-derived von Willebrand factor preventively for at least 12 months. Plasma-derived means the product was produced from human plasma (the liquid part of blood).
In the 13 patients who had previously been using on-demand treatment, preventive treatment with Veyvondi reduced the number of annual bleedings by about 92% compared with the average number in the year before Veyvondi treatment.
In the 10 patients who had been receiving a plasma-derived von Willebrand factor to prevent bleedings, preventive treatment with Veyvondi reduced the number of annual bleedings by 45% compared with the average number in the year before switching to Veyvondi.
For the full list of side effects with Veyvondi, see the package leaflet.
The most common side effect with Veyvondi (which may affect more than 1 in 10 people) is headache. The following side effects may also occur during treatment with Veyvondi: hypersensitivity (allergic) reactions, thromboembolic events (problems due to the formation of blood clots in the blood vessels), development of inhibitors (antibodies) against von Willebrand factor, causing the medicine to stop working and resulting in a loss of bleeding control.
Veyvondi must not be used in patients who have had allergic reactions to mouse or hamster proteins.
Veyvondi was shown to be effective in preventing and treating bleeding episodes in patients with von Willebrand disease. Veyvondi was also effective for preventing and treating bleedings related to surgery. Veyvondi should be used only when desmopressin (the main treatment for von Willebrand disease) cannot be used or is not working well enough. The Agency noted that there are uncertainties related to the small number of patients recruited in the studies and the lack of a direct comparator; however, this was considered acceptable given the rarity of the disease. The side effects with Veyvondi were considered typical for this type of medicine.
The European Medicines Agency therefore decided that Veyvondi’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Veyvondi have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Veyvondi are continuously monitored. Side effects reported with Veyvondi are carefully evaluated and any necessary action taken to protect patients.
Veyvondi received a marketing authorisation valid throughout the EU on 31 August 2018.
Product information
Latest procedure affecting product information:
II/0033
11/07/2024
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
- Veyvondi
- Active substance
- vonicog alfa
- International non-proprietary name (INN) or common name
- vonicog alfa
- Therapeutic area (MeSH)
- von Willebrand Diseases
- Anatomical therapeutic chemical (ATC) code
- B02BD10
Pharmacotherapeutic group
AntihemorrhagicsTherapeutic indication
Prevention and treatment of haemorrhage or surgical bleeding in adults (age 18 years and older) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.
Veyvondi should not be used in the treatment of Haemophilia A.
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