Zinbryta

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

Table of contents

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 - Annex I (PDF/644.26 KB)


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

    • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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