Zinbryta

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

EMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver damage

Zinbryta to be used in restricted patient group, with strict liver monitoring

On 9 November 2017, the European Medicines Agency (EMA) concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage.

The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment. In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.

Zinbryta should now only be used in patients who have had an inadequate response to at least two disease modifying therapies (DMTs) and cannot be treated with any other DMTs. Details of the recommendations for patients and healthcare professionals are given below.

The review of the liver effects of Zinbryta was conducted by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which issued recommendations in October 2017. The Committee for Medicinal Products for Human Use (CHMP) then adopted EMA's final opinion, which was sent to the European Commission for adoption of a legally binding decision.

Key facts

About this medicine
Approved name
Zinbryta
International non-proprietary name (INN) or common name
daclizumab
Associated names
Zinbryta
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-20/1456/C/003862/0010
Type
Article 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally authorised product(s)
Key dates and outcomes
Procedure start date
09/06/2017
PRAC recommendation date
26/10/2017
CHMP opinion/CMDh position date
09/11/2017
EC decision date
08/01/2018
Outcome
Risk minimisation measures

All documents

Procedure started

Under evaluation

  • List item

    Zinbryta Article-20 referral - Assessment report on provisional measures (PDF/171.5 KB)

    Adopted

    First published: 19/07/2017
    Last updated: 01/09/2017
    EMA/453660/2017 Rev. 1

  • List item

    Zinbryta Article-20 referral - Annex IV - Scientific conclusions (PDF/44.21 KB)


    First published: 19/07/2017
    Last updated: 19/07/2017

  • List item

    Zinbryta Article-20 referral - Summary of provisional measures (PDF/96.17 KB)


    First published: 07/07/2017
    Last updated: 17/11/2017
    EMA/424159/2017

  • List item

    Zinbryta Article-20 referral - Annex III (PDF/661.44 KB)


    First published: 07/07/2017
    Last updated: 01/09/2017

  • Recommendation provided by Pharmacovigilance Risk Assessment Committee

    Opinion provided by Committee for Medicinal Products for Human Use

    European Commission final decision

  • List item

    Zinbryta Article-20 referral - EMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver damage (PDF/89.16 KB)


    First published: 10/11/2017
    Last updated: 12/01/2018
    EMA/753277/2017

  • List item

    Zinbryta Article-20 referral - Annex IV (PDF/38.66 KB)


    First published: 12/01/2018
    Last updated: 12/01/2018

  • List item

    Zinbryta Article-20 referral - PRAC assessment report (PDF/241.57 KB)


    First published: 12/01/2018
    Last updated: 12/01/2018
    EMA/779877/2017

  • List item

    Zinbryta Article-20 referral - Annex I (PDF/644.26 KB)


    First published: 12/01/2018
    Last updated: 12/01/2018

  • List item

    Zinbryta Article-20 referral - EMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver damage (PDF/89.16 KB)


    First published: 10/11/2017
    Last updated: 12/01/2018
    EMA/753277/2017

  • Document description

    • Annex I - List of the medicines affected by the referral
    • Annex II - Scientific conclusions of the CHMP or CMDh
    • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
    • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
    • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
    • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
    • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
    • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
    • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

    News

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