Vpriv
Authorised
This medicine is authorised for use in the European Union
velaglucerase alfa
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Vpriv. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vpriv.
Vpriv is a powder that is made up into a solution for infusion (drip) into a vein. It contains the active substance velaglucerase alfa.
Vpriv is used for the long-term treatment of patients with Gaucher disease. Gaucher disease is a rare inherited disorder, in which people do not have enough of an enzyme called glucocerebrosidase, which normally breaks down a fat called glucocerebroside. Without the enzyme, glucocerebroside builds up in the body, typically in the liver, spleen and bone, which produces the symptoms of the disease: anaemia (low red-blood-cell counts), tiredness, easy bruising and a tendency to bleed, an enlarged spleen and liver, and bone pain and breaks.
Vpriv is used in patients who have type-1 Gaucher disease, the type that usually affects the liver, spleen and bones.
Because the number of patients with Gaucher disease is low, the disease is considered ‘rare’, and Vpriv was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 June 2010.
The medicine can only be obtained with a prescription.
Vpriv treatment should be supervised by a doctor experienced in managing Gaucher disease.
The recommended dose of Vpriv is 60 units/kg bodyweight, which is given as a one?hour infusion once every two weeks. The dose can be adjusted according to each patient’s symptoms and response to treatment. The first three infusions are given in hospital, but subsequent infusions may be given at home in patients who tolerate the medicine well. Home infusions should be supervised by a healthcare professional trained in emergency measures.
Gaucher disease occurs because of the lack of an enzyme called glucocerebrosidase. Velaglucerase alfa replaces the missing enzyme in Gaucher disease, helping to break down glucocerebroside and stopping it building up in the body.
In one main study involving 35 patients (including 9 children) with type 1 Gaucher disease, Vpriv was compared with imiglucerase (another medicine for Gaucher disease). The main measure of effectiveness was the improvement in anaemia, one of the symptoms of the disease, after 41 weeks. The study also looked at control of other signs of the disease such as the increase in the number of platelets in the blood, and the reduction of the size of the liver and spleen.
Vpriv was as effective as imiglucerase at reducing anaemia. Vpriv increased the amount of haemoglobin (the protein in red blood cells that carries oxygen) by an average of 1.6 grams per decilitre (from 11.4 g/dl) while imiglucerase increased the amount of haemoglobin by an average of 1.5 g/dl (from 10.6 g/dl). The study also showed that Vpriv is as effective as imiglucerase in controlling other signs of Gaucher disease.
In studies, the most common side effects with Vpriv (seen in more than 1 patient in 10) were abdominal (belly) pain, headache, dizziness, bone pain, arthralgia (joint pain), back pain, infusion-related reactions, asthenia (weakness) or fatigue (tiredness), and pyrexia (fever) or increased body temperature. For the full list of all side effects and restrictions with Vpriv, see the package leaflet.
Vpriv must not be used in people who have a severe allergic reaction to velaglucerase alfa or any of the other ingredients.
The CHMP decided that Vpriv’s benefits are greater than its risks and recommended that it be given marketing authorisation.
A risk management plan has been developed to ensure that Vpriv is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vpriv, including the appropriate precautions to be followed by healthcare professionals and patients.
The European Commission granted a marketing authorisation valid throughout the European Union for Vpriv to Shire Pharmaceuticals Ireland Limited on 26 August 2010.
For more information about treatment with Vpriv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
II/0054
25/05/2023
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
- Vpriv
- Active substance
- velaglucerase alfa
- International non-proprietary name (INN) or common name
- velaglucerase alfa
- Therapeutic area (MeSH)
- Gaucher Disease
- Anatomical therapeutic chemical (ATC) code
- A16AB10
Pharmacotherapeutic group
Other alimentary tract and metabolism productsTherapeutic indication
Vpriv is indicated for long-term enzyme-replacement therapy (ERT) in patients with type-1 Gaucher disease.
Topics
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