Aubagio

teriflunomide

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This is a summary of the European public assessment report (EPAR) for Aubagio. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Aubagio.

What is Aubagio and what is it used for?

Aubagio is a medicine that contains the active substance teriflunomide. It is used to treat adults with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves. Aubagio is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).

How is Aubagio used?

Aubagio can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the management of MS.

Aubagio is available as tablets (14 mg). The recommended dose is 14 mg once a day.

How does Aubagio work?

In MS, the body’s immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord), causing the inflammation that damages the nerve sheaths. The active substance in Aubagio, teriflunomide, blocks an enzyme called ‘dihydro-orotate dehydrogenase’ which is necessary for cells to multiply. The exact way teriflunomide works in MS is not known but it is thought to reduce the number of lymphocytes which form part of the immune system and are involved in the inflammation process. With fewer lymphocytes, there is less inflammation, helping to control the symptoms of MS.

What benefits of Aubagio have been shown in studies?

Aubagio has been studied in four main studies involving over 2,700 adults with relapsing-remitting MS.

One study involving 179 patients compared the effects of Aubagio with placebo (a dummy treatment) on the number of active lesions (developing areas of damage) in the brain detected by a brain scan. Aubagio was found to be more effective than placebo: after around 9 months (36 weeks), the number of active lesions was around 1 per scan in patients who were taking Aubagio compared with around 2.7 in patients taking placebo.

Two studies involving 2,257 patients compared the effects of Aubagio with placebo in reducing the number of relapses per patient per year (called the ‘annualised relapse rate’). Treatment lasted for up to about three years (152 weeks). Aubagio was found to be more effective than placebo: in patients taking Aubagio, relapses were reduced by around 30% more than in patients taking placebo (the annualised relapse rate was 0.35 for Aubagio compared with 0.53 for placebo). The studies also looked at the effect of Aubagio on the changes in the patients’ level of disability and showed that the risk of disability getting worse was reduced by 30% in comparison with placebo after around two and a half years (132 weeks) of treatment.

The fourth study, involving 324 patients, compared the effects of Aubagio with interferon beta-1a (another treatment for MS) on the rate of treatment failure, by looking at the time until patients had their first relapse or permanently stopped their treatment. The study lasted for up to two years. The results of the study were inconclusive. A 13.5% rate of permanent discontinuation was seen in patients taking Aubagio, compared with 24% in patients taking interferon beta-1a. However, the rate of relapse was 23.4% with Aubagio compared with 15.4% with interferon beta-1a. Overall, no conclusion could be reached from this study on any differences between Aubagio and interferon beta-1a for MS treatment.

What are the risks associated with Aubagio?

The most commonly reported side effects with Aubagio (which may affect more than 1 in 10 people) are influenza (flu), upper-respiratory-tract infection (cold), urinary-tract infection (infection of the structures that carry urine), paraesthesia (abnormal sensations like pins and needles), diarrhoea, increased liver enzymes, nausea (feeling sick), and alopecia (hair loss). In general, diarrhoea, nausea and alopecia are mild to moderate, resolve with time and do not usually lead to treatment being stopped. For the full list of all side effects reported with Aubagio, see the package leaflet.

Aubagio must not be used in patients with:

  • severe liver disease;
  • severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);
  • poor bone-marrow function or low blood cell counts (red cells, white cells or platelets);
  • serious infections;
  • severe kidney disease that requires dialysis;
  • severe hypoproteinaemia (low blood protein levels).

Aubagio must also not be used in pregnant women or during breast-feeding. Women of childbearing potential must not take Aubagio without using reliable contraceptive measures. For the full list of restrictions, see the package leaflet.

Why is Aubagio approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Aubagio’s benefits are greater than its risks and recommended that it be approved for use in the EU. In studies, Aubagio was shown to reduce relapses and delay the progression of disability in patients with relapsing-remitting MS. Although the effects were modest, they were considered to be significant and similar to other MS treatments, although there were no conclusive results available from a direct comparison with interferon beta-1a. Aubagio is given by mouth which was considered to be an advantage over other medicines such as interferon beta-1a. Regarding its safety, side effects were similar to the immunosuppressant leflunomide, as leflunomide is converted into teriflunomide in the body. The risk of serious side effects affecting the liver and bone marrow was considered manageable and adequately addressed by risk-minimisation measures.

What measures are being taken to ensure the safe and effective use of Aubagio?

A risk-management plan has been developed to ensure that Aubagio 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 Aubagio, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that makes Aubagio must ensure that all healthcare professionals who are expected to use Aubagio receive an information pack containing important safety information, including the tests and monitoring that should be carried out in patients before and after starting treatment. The pack will also include information on a registry the company will set up to collect data on babies born to women treated with Aubagio, as well as a patient reminder card with key safety information for patients.

Other information about Aubagio

The European Commission granted a marketing authorisation valid throughout the European Union for Aubagio on 26 August 2013.

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

Name Language First published Last updated
Aubagio : EPAR - Summary for the public BG = bălgarski 06/09/2013  
Aubagio : EPAR - Summary for the public ES = español 06/09/2013  
Aubagio : EPAR - Summary for the public CS = čeština 06/09/2013  
Aubagio : EPAR - Summary for the public DA = dansk 06/09/2013  
Aubagio : EPAR - Summary for the public DE = Deutsch 06/09/2013  
Aubagio : EPAR - Summary for the public ET = eesti keel 06/09/2013  
Aubagio : EPAR - Summary for the public EL = elliniká 06/09/2013  
Aubagio : EPAR - Summary for the public EN = English 06/09/2013  
Aubagio : EPAR - Summary for the public FR = français 06/09/2013  
Aubagio : EPAR - Summary for the public IT = italiano 06/09/2013  
Aubagio : EPAR - Summary for the public LV = latviešu valoda 06/09/2013  
Aubagio : EPAR - Summary for the public LT = lietuvių kalba 06/09/2013  
Aubagio : EPAR - Summary for the public HU = magyar 06/09/2013  
Aubagio : EPAR - Summary for the public MT = Malti 06/09/2013  
Aubagio : EPAR - Summary for the public NL = Nederlands 06/09/2013  
Aubagio : EPAR - Summary for the public PL = polski 06/09/2013  
Aubagio : EPAR - Summary for the public PT = português 06/09/2013  
Aubagio : EPAR - Summary for the public RO = română 06/09/2013  
Aubagio : EPAR - Summary for the public SK = slovenčina 06/09/2013  
Aubagio : EPAR - Summary for the public SL = slovenščina 06/09/2013  
Aubagio : EPAR - Summary for the public FI = suomi 06/09/2013  
Aubagio : EPAR - Summary for the public SV = svenska 06/09/2013  
Aubagio : EPAR - Summary for the public HR = Hrvatski 06/09/2013  

This EPAR was last updated on 28/11/2014 .

Authorisation details

Product details

Product details for Aubagio
NameAubagio
Agency product numberEMEA/H/C/002514
Active substance

teriflunomide

International non-proprietary name (INN) or common name

teriflunomide

Therapeutic area Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code L04AA31
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 Aubagio
Marketing-authorisation holder

Sanofi-aventis Groupe  

Revision3
Date of issue of marketing authorisation valid throughout the European Union26/08/2013

Contact address:

Sanofi-aventis Groupe
174, avenue de France
F-75013 Paris
France

Product information

Product information

20/11/2014  Aubagio -EMEA/H/C/002514 -PSUV/0005

Name Language First published Last updated
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014
Aubagio : EPAR - Product Information HR = Hrvatski 06/09/2013 28/11/2014

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
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  
Aubagio : EPAR - All Authorised presentations HR = Hrvatski 06/09/2013  

Pharmacotherapeutic group

Selective immunosuppressant

Therapeutic indication

Treatment of adult patients with relapsing-remitting multiple sclerosis (MS).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Aubagio : EPAR - Public assessment report HR = Hrvatski 06/09/2013  
CHMP summary of positive opinion for Aubagio HR = Hrvatski 28/06/2013  
CHMP summary of positive opinion for Aubagio HR = Hrvatski 22/03/2013  

Authorised

This medicine is approved for use in the European Union