Vpriv

velaglucerase alfa

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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.

What is Vpriv?

Vpriv is a powder that is made up into a solution for infusion (a drip into a vein). It contains the active substance velaglucerase alfa.

What is Vpriv used for?

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.

How is Vpriv used?

Vpriv treatment should be supervised by a doctor experienced in managing Gaucher disease.

Vpriv is given as a oneā€‘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 given at home administration can be considered in patients who tolerate the medicine well. Home infusions should be supervised by a healthcare professional.

How does Vpriv work?

Gaucher disease occurs because of the lack of an enzyme called glucocerebrosidase. The active substance in Vpriv, velaglucerase alfa, is a copy of this enzyme, which is produced by a method known as ‘recombinant DNA technology’: the enzyme is made by activating a gene in a human cell that makes it able to produce this enzyme. Velaglucerase alfa replaces the missing enzyme in Gaucher disease, helping to break down glucocerebroside and stopping it building up in the body.

How has Vpriv been studied?

The effects of Vpriv were first tested in experimental models before being studied in humans.

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.

What benefit has Vpriv shown during the studies?

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 symptoms of Gaucher disease.

What is the risk associated with Vpriv?

In studies, the most common side effects with Vpriv (seen in more than 1 patient in 10) were 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 reported 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.

Why has Vpriv been approved?

The CHMP decided that Vpriv’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Vpriv:

The European Commission granted a marketing authorisation valid throughout the European Union for Vpriv to Shire Pharmaceuticals Ireland Limited on 26 August 2010. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Vpriv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Vpriv : EPAR - Summary for the public BG = bălgarski 10/09/2010  
Vpriv : EPAR - Summary for the public ES = español 10/09/2010  
Vpriv : EPAR - Summary for the public CS = čeština 10/09/2010  
Vpriv : EPAR - Summary for the public DA = dansk 10/09/2010  
Vpriv : EPAR - Summary for the public DE = Deutsch 10/09/2010  
Vpriv : EPAR - Summary for the public ET = eesti keel 10/09/2010  
Vpriv : EPAR - Summary for the public EL = elliniká 10/09/2010  
Vpriv : EPAR - Summary for the public EN = English 10/09/2010  
Vpriv : EPAR - Summary for the public FR = français 10/09/2010  
Vpriv : EPAR - Summary for the public IT = italiano 10/09/2010  
Vpriv : EPAR - Summary for the public LV = latviešu valoda 10/09/2010  
Vpriv : EPAR - Summary for the public LT = lietuvių kalba 10/09/2010  
Vpriv : EPAR - Summary for the public HU = magyar 10/09/2010  
Vpriv : EPAR - Summary for the public MT = Malti 10/09/2010  
Vpriv : EPAR - Summary for the public NL = Nederlands 10/09/2010  
Vpriv : EPAR - Summary for the public PL = polski 10/09/2010  
Vpriv : EPAR - Summary for the public PT = português 10/09/2010  
Vpriv : EPAR - Summary for the public RO = română 10/09/2010  
Vpriv : EPAR - Summary for the public SK = slovenčina 10/09/2010  
Vpriv : EPAR - Summary for the public SL = slovenščina 10/09/2010  
Vpriv : EPAR - Summary for the public FI = suomi 10/09/2010  
Vpriv : EPAR - Summary for the public SV = svenska 10/09/2010  

This EPAR was last updated on 04/09/2014 .

Authorisation details

Product details

Product details for Vpriv
NameVpriv
Agency product numberEMEA/H/C/001249
Active substance

velaglucerase alfa

International non-proprietary name (INN) or common name

velaglucerase alfa

Therapeutic area Gaucher Disease
Anatomical therapeutic chemical (ATC) code A16AB10
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Vpriv
Marketing-authorisation holder

Shire Pharmaceuticals Ireland Ltd.
 

Revision5
Date of issue of marketing authorisation valid throughout the European Union26/08/2010

Contact address:

Shire Pharmaceuticals Ireland Ltd.
5 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Product information

Product information

19/12/2013  Vpriv -EMEA/H/C/001249 -II/0015

Name Language First published Last updated
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014
Vpriv : EPAR - Product Information SV = svenska 10/09/2010 04/09/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013
Vpriv : EPAR - All Authorised presentations SV = svenska 10/09/2010 15/05/2013

Pharmacotherapeutic group

Other alimentary-tract and metabolism products

Therapeutic indication

Vpriv is indicated for long-term enzyme-replacement therapy (ERT) in patients with type-1 Gaucher disease.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Vpriv : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 18/11/2010 04/09/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Vpriv : EPAR - Public assessment report SV = svenska 10/09/2010  
CHMP summary of positive opinion for Vpriv SV = svenska 25/06/2010  

Authorised

This medicine is approved for use in the European Union

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