Zinbryta

daclizumab

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

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

What is Zinbryta and what is it used for?

Zinbryta is a medicine used to treat adults with the relapsing forms of multiple sclerosis. Multiple sclerosis is a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord. Relapsing means that the patient has flare-ups of the symptoms.

Zinbryta contains the active substance daclizumab.

How is Zinbryta used?

Zinbryta can only be obtained with a prescription and treatment should be started by a doctor with experience in managing multiple sclerosis. The recommended dose is 150 mg once a month by injection under the skin. Patients should be trained to give themselves the injection using either a prefilled syringe or an injection pen device. For further information, see the package leaflet.

How does Zinbryta work?

In multiple sclerosis, the body’s immune (defence) system incorrectly attacks and damages the protective sheath around the nerve cells in the central nervous system (the brain and spinal cord). The active substance in Zinbryta, daclizumab, is a monoclonal antibody that attaches to T cells. These cells form part of the body’s immune system and they are activated by interleukin-2, a signalling protein in the body. By attaching to the T cells, daclizumab blocks interleukin-2, so preventing T cells from attacking and damaging nerve cells. Daclizumab may also have other effects that reduce the immune system’s damaging effects on nerve cells.

What benefits of Zinbryta have been shown in studies?

Zinbryta has been found effective for treating relapsing multiple sclerosis in two main studies involving over 2,400 patients.

In one study involving 600 patients, Zinbryta was found to be more effective than placebo (a dummy treatment) at reducing relapses of the condition. Patients receiving Zinbryta 150 mg every 4 weeks had on average 0.21 relapses over a year compared with 0.46 in those receiving placebo.

In another study involving 1,841 patients, patients receiving Zinbryta 150 mg every 4 weeks had on average 0.22 relapses over a year compared with 0.39 in those receiving interferon beta-1a, another medicine used for multiple sclerosis.

What are the risks associated with Zinbryta?

The most common side effects with Zinbryta (which may affect more than 1 in 100 people) are rash, increased liver enzymes in the blood, depression, inflamed and sore nose and throat, influenza and upper respiratory tract infection such as colds and lymphadenopathy (swollen glands). The most common serious side effects of Zinbryta are liver damage and severe skin reactions. For the full list of restrictions and of all side effects reported with Zinbryta, see the package leaflet.

Why is Zinbryta approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Zinbryta’s benefits are greater than its risks and recommended that it be approved for use in the EU. Zinbryta has been found to be effective in studies carried out over up to 3 years. Zinbryta works in a different way to existing treatments and has the advantage that it is given just once a month. Treatment is associated with adverse effects on the liver and an increased risk of infections but the CHMP considered these could be managed with regular monitoring.

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

The company that markets Zinbryta will issue educational materials for healthcare professionals and for patients about liver damage and how to prevent or reduce the damage.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinbryta have also been included in the summary of product characteristics and the package leaflet.

Other information about Zinbryta

The European Commission granted a marketing authorisation valid throughout the European Union for Zinbryta on 1 July 2016.

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

Name Language First published Last updated
Zinbryta : EPAR - Summary for the public BG = bălgarski 2016-07-19  
Zinbryta : EPAR - Summary for the public ES = español 2016-07-19  
Zinbryta : EPAR - Summary for the public CS = čeština 2016-07-19  
Zinbryta : EPAR - Summary for the public DA = dansk 2016-07-19  
Zinbryta : EPAR - Summary for the public DE = Deutsch 2016-07-19  
Zinbryta : EPAR - Summary for the public ET = eesti keel 2016-07-19  
Zinbryta : EPAR - Summary for the public EL = elliniká 2016-07-19  
Zinbryta : EPAR - Summary for the public EN = English 2016-07-19  
Zinbryta : EPAR - Summary for the public FR = français 2016-07-19  
Zinbryta : EPAR - Summary for the public IT = italiano 2016-07-19  
Zinbryta : EPAR - Summary for the public LV = latviešu valoda 2016-07-19  
Zinbryta : EPAR - Summary for the public LT = lietuvių kalba 2016-07-19  
Zinbryta : EPAR - Summary for the public HU = magyar 2016-07-19  
Zinbryta : EPAR - Summary for the public MT = Malti 2016-07-19  
Zinbryta : EPAR - Summary for the public NL = Nederlands 2016-07-19  
Zinbryta : EPAR - Summary for the public PL = polski 2016-07-19  
Zinbryta : EPAR - Summary for the public PT = português 2016-07-19  
Zinbryta : EPAR - Summary for the public RO = română 2016-07-19  
Zinbryta : EPAR - Summary for the public SK = slovenčina 2016-07-19  
Zinbryta : EPAR - Summary for the public SL = slovenščina 2016-07-19  
Zinbryta : EPAR - Summary for the public FI = suomi 2016-07-19  
Zinbryta : EPAR - Summary for the public SV = svenska 2016-07-19  
Zinbryta : EPAR - Summary for the public HR = Hrvatski 2016-07-19  

This EPAR was last updated on 19/07/2017 .

Authorisation details

Product details

Product details for Zinbryta
NameZinbryta
Agency product numberEMEA/H/C/003862
Active substance

daclizumab

International non-proprietary name (INN) or common name

daclizumab

Therapeutic area Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code L04AC01
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 Zinbryta
Marketing-authorisation holder

Biogen Idec Ltd

Revision4
Date of issue of marketing authorisation valid throughout the European Union01/07/2016

Contact address:

Biogen Idec Ltd
Innovation House 
70 Norden Road 
Maidenhead 
Berkshire SL6 4AY 
United Kingdom

Product information

Product information

14/07/2017  Zinbryta -EMEA/H/C/003862 -A20/0010

Name Language First published Last updated
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-07-19

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
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Zinbryta is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Zinbryta : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-09-22 2017-07-19

Initial marketing-authorisation documents

Name Language First published Last updated
Zinbryta : EPAR - Public assessment report HR = Hrvatski 2016-07-19  
CHMP summary of opinion for Zinbryta HR = Hrvatski 2016-04-29