Xadago

safinamide

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

For practical information about using Xadago, patients should read the package leaflet or contact their doctor or pharmacist.

What is Xadago and what is it used for?

Xadago is a medicine used to treat Parkinson’s disease, a progressive brain disorder that causes shaking, slow movement and muscular stiffness. It is used in addition to levodopa (a medicine commonly used to treat the symptoms of Parkinson’s disease) either alone or in combination with other medicines for Parkinson’s, in patients with mid- to late-stage Parkinson’s disease who are having ‘motor fluctuations’. These fluctuations occur when the effect of levodopa wears off and the patient suddenly switches from being ‘on’ and able to move about to being ‘off’ and having difficulty moving about.

Xadago contains the active substance safinamide.

How is Xadago used?

Xadago is available as tablets (50 and 100 mg) and can only be obtained with a prescription. Treatment should be started at a dose of 50 mg a day and the doctor may increase the dose up to 100 mg a day based on patient’s need.

For further information, see the package leaflet.

How does Xadago work?

In patients with Parkinson’s disease, certain cells in the brain that produce dopamine die, and as dopamine is involved in controlling movement, the patient's movement worsens over time.

The active substance in Xadago, safinamide, is a ‘monoamine oxidase-B (MAO-B) inhibitor’. It blocks the enzyme monoamine oxidase type B (which breaks down dopamine), thereby helping to restore dopamine levels in the brain and improving the patient's symptoms.

What benefits of Xadago have been shown in studies?

Xadago, as an add-on treatment to levodopa with or without other medicines for Parkinson’s disease, has been compared with placebo (a dummy treatment) in two main studies involving 1,218 patients with late stage Parkinson’s disease who experienced fluctuations. In both studies, 6 months treatment with Xadago increased the time during the day during which patients were ‘on’ and able to move by 30-60 minutes when compared with placebo. Another study showed maintenance of this effect for 24 months.

Xadago was also investigated as an add-on to treatment in 2 studies in patients with early Parkinson’s disease without fluctuations, but these studies did not show a clear benefit and the company did not pursue this use as part of the application.

What are the risks associated with Xadago?

The most common side effects with Xadago (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), dyskinesia (difficulty controlling movement), somnolence (sleepiness), dizziness, headache, worsening of existing Parkinson’s disease, cataract (clouding of the lens), orthostatic hypotension (drop in blood pressure when standing up), nausea (feeling sick) and falls. For the full list of all side effects reported with Xadago, see the package leaflet.

Xadago must not be used in patients with severe liver problems, in patients treated with pethidine or other MAO inhibiting medicines, or in patients with certain conditions affecting the eyes. For the full list of restrictions, see the package leaflet.

Why is Xadago approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Xadago’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee concluded that the effect of Xadago on the daily time that patients lived without motor symptoms was of clinical relevance, also taking into account the response reported in the literature for other Parkinson’s medicines. This effect was also maintained in the long-term. Regarding safety, in overall it was considered acceptable.

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

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

Further information can be found in the summary of the risk management plan.

Other information about Xadago

The European Commission granted a marketing authorisation valid throughout the European Union for Xadago on 24 February 2015.

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

Name Language First published Last updated
Xadago : EPAR - Summary for the public BG = bălgarski 30/03/2015  
Xadago : EPAR - Summary for the public ES = español 30/03/2015  
Xadago : EPAR - Summary for the public CS = čeština 30/03/2015  
Xadago : EPAR - Summary for the public DA = dansk 30/03/2015  
Xadago : EPAR - Summary for the public DE = Deutsch 30/03/2015  
Xadago : EPAR - Summary for the public ET = eesti keel 30/03/2015  
Xadago : EPAR - Summary for the public EL = elliniká 30/03/2015  
Xadago : EPAR - Summary for the public EN = English 30/03/2015  
Xadago : EPAR - Summary for the public FR = français 30/03/2015  
Xadago : EPAR - Summary for the public IT = italiano 30/03/2015  
Xadago : EPAR - Summary for the public LV = latviešu valoda 30/03/2015  
Xadago : EPAR - Summary for the public LT = lietuvių kalba 30/03/2015  
Xadago : EPAR - Summary for the public HU = magyar 30/03/2015  
Xadago : EPAR - Summary for the public MT = Malti 30/03/2015  
Xadago : EPAR - Summary for the public NL = Nederlands 30/03/2015  
Xadago : EPAR - Summary for the public PL = polski 30/03/2015  
Xadago : EPAR - Summary for the public PT = português 30/03/2015  
Xadago : EPAR - Summary for the public RO = română 30/03/2015  
Xadago : EPAR - Summary for the public SK = slovenčina 30/03/2015  
Xadago : EPAR - Summary for the public SL = slovenščina 30/03/2015  
Xadago : EPAR - Summary for the public FI = suomi 30/03/2015  
Xadago : EPAR - Summary for the public SV = svenska 30/03/2015  
Xadago : EPAR - Summary for the public HR = Hrvatski 30/03/2015  
Name Language First published Last updated
Xadago : EPAR - Risk-management-plan summary (English only) 30/03/2015  

This EPAR was last updated on 22/06/2016 .

Authorisation details

Product details

Product details for Xadago
NameXadago
Agency product numberEMEA/H/C/002396
Active substance

safinamide methanesulfonate

International non-proprietary name (INN) or common name

safinamide

Therapeutic area Parkinson Disease
Anatomical therapeutic chemical (ATC) code N04B
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 Xadago
Marketing-authorisation holder

Zambon SpA

Revision4
Date of issue of marketing authorisation valid throughout the European Union24/02/2015

Contact address:

Zambon SpA
Via Lillo Del Duca 10 
20091 Bresso (Milan) 
Italy

Product information

Product information

26/05/2016  Xadago -EMEA/H/C/002396 -II/0005

Name Language First published Last updated
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016
Xadago : EPAR - Product Information EN = English 30/03/2015 22/06/2016

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
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  
Xadago : EPAR - All Authorised presentations EN = English 30/03/2015  

Pharmacotherapeutic group

Anti-Parkinson drugs

Therapeutic indication

Xadago is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Xadago : EPAR - Procedural steps taken and scientific information after authorisation EN = English 06/11/2015 22/06/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Xadago : EPAR - Public assessment report EN = English 30/03/2015  
CHMP summary of positive opinion for Xadago EN = English 19/12/2014  

Authorised

This medicine is approved for use in the European Union