Benlysta

belimumab

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This is a summary of the European public assessment report (EPAR) for Benlysta. 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 Benlysta.

What is Benlysta?

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

What is Benlysta used for?

Benlysta is used as an add-on treatment for systemic lupus erythematosus (SLE) in adults with a positive auto-antibody test whose disease is still highly active despite standard treatment.

The medicine can only be obtained with a prescription.

How is Benlysta used?

Benlysta treatment should only be started and supervised by a doctor who has experience in the diagnosis and treatment of SLE.

Benlysta is given as an infusion into a vein over a one-hour period. The recommended dose is 10 mg per kilogram body weight. The first three doses are given at two-week intervals. After this, Benlysta is given once every four weeks.

The doctor may have to interrupt or stop treatment if the patient develops reactions linked to the infusion (such as rash, itchiness and difficulty breathing) or hypersensitivity (allergic) reactions, which may be severe and life-threatening and can develop several hours after Benlysta is given. Patients should therefore be observed for several hours after at least the first two infusions and Benlysta should always be given to patients in a place where these reactions can be managed immediately if they occur.

How does Benlysta work?

SLE is a disease in which the immune system (the body’s natural defences) attacks the cells and tissues of the patient, causing inflammation and organ damage. It can affect almost any organ in the body, and is thought to involve a type of white blood cell called B lymphocytes. Usually, B lymphocytes produce antibodies which are proteins that help to fight infections. In SLE, some of these antibodies attack the body’s own cells and organs instead (auto-antibodies).

The active substance in Benlysta, belimumab, is a monoclonal antibody. A monoclonal antibody is an antibody that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body. Belimumab has been designed to attach to and block a protein called BLyS which helps B lymphocytes to live longer. By blocking the action of BLyS, belimumab reduces the life span of B lymphocytes, thereby reducing the inflammation and organ damage that occur in SLE.

How has Benlysta been studied?

Benlysta (given at doses of 1 and 10 mg per kilogram bodyweight) has been compared with placebo (a dummy treatment) in two main studies involving 1,693 adult patients with active SLE. The patients continued to receive their standard treatments for SLE during the studies. In both studies, the main measure of effectiveness was the number of patients whose disease activity decreased to a certain level after 12 months.

What benefit has Benlysta shown during the studies?

Benlysta was shown to be more effective than placebo in reducing disease activity when used as an add-on treatment for SLE. In the first study, in 43% of patients Benlysta 10 mg/kg was effective, compared with 34% of patients who were given placebo. In the second study, in 58% of patients Benlysta 10 mg/kg was effective compared with 44% of patients who were given placebo. In both studies, the 10 mg/kg dose of Benlysta was more effective than the 1 mg/kg dose.

What is the risk associated with Benlysta?

The most common side effects with Benlysta (seen in more than 1 patient in 10) are bacterial infections, such as bronchitis (inflammation of the airways in the lungs) and cystitis (inflammation in the bladder), diarrhoea and nausea (feeling sick). For the full list of all side effects reported with Benlysta, see the package leaflet.

Benlysta must not be used in people who are hypersensitive (allergic) to belimumab or any of the other ingredients.

Why has Benlysta been approved?

The CHMP considered that Benlysta, used as an add-on treatment, reduced disease activity in SLE without serious risk to the patient. The medicine may cause infusion and hypersensitivity reactions as well as infections, but is generally well tolerated. The CHMP also noted the lack of effective alternative treatments for patients who have already tried standard treatments. The Committee decided that Benlysta’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Benlysta

The European Commission granted a marketing authorisation valid throughout the European Union for Benlysta on 13 July 2011.

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

Name Language First published Last updated
Benlysta : EPAR - Summary for the public BG = bălgarski 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public ES = español 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public CS = čeština 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public DA = dansk 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public DE = Deutsch 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public ET = eesti keel 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public EL = elliniká 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public EN = English 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public FR = français 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public IT = italiano 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public LV = latviešu valoda 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public LT = lietuvių kalba 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public HU = magyar 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public MT = Malti 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public NL = Nederlands 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public PL = polski 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public PT = português 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public RO = română 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public SK = slovenčina 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public SL = slovenščina 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public FI = suomi 09/08/2011 13/11/2012
Benlysta : EPAR - Summary for the public SV = svenska 09/08/2011 13/11/2012

This EPAR was last updated on 07/11/2014 .

Authorisation details

Product details

Product details for Benlysta
NameBenlysta
Agency product numberEMEA/H/C/002015
Active substance

belimumab

International non-proprietary name (INN) or common name

belimumab

Therapeutic area Lupus Erythematosus, Systemic
Anatomical therapeutic chemical (ATC) code L04AA26
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Benlysta
Marketing-authorisation holder

Glaxo Group Ltd.

Revision10
Date of issue of marketing authorisation valid throughout the European Union13/07/2011

Contact address:

Glaxo Group Ltd.
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex
UB6 0NN
United Kingdom

Product information

Product information

01/10/2014  Benlysta -EMEA/H/C/002015 -IB/0030/G

Name Language First published Last updated
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014
Benlysta : EPAR - Product Information SV = svenska 09/08/2011 07/11/2014

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
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012
Benlysta : EPAR - All Authorised presentations SV = svenska 09/08/2011 13/11/2012

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Benlysta is indicated as add-on therapy in adult patients with active, auto-antibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Benlysta : EPAR - Public assessment report SV = svenska 09/08/2011  
CHMP summary of positive opinion for Benlysta SV = svenska 20/05/2011  

Authorised

This medicine is approved for use in the European Union