Zinbryta
- Procedure started
- Under evaluation
- PRAC recommendation
- CHMP opinion
- European Commission final decision
Table of contents
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
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Approved name |
Zinbryta
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International non-proprietary name (INN) or common name |
daclizumab
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Associated names |
Zinbryta
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Class |
-
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About this procedure
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Current status |
European Commission final decision
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Reference number |
EMEA/H/A-20/1456/C/003862/0010
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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. |
Authorisation model |
Centrally authorised product(s)
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Decision making model |
PRAC-CHMP-EC
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Key dates and outcomes
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Procedure start date |
09/06/2017
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PRAC recommendation date |
26/10/2017
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CHMP opinion/CMDh position date |
09/11/2017
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EC decision date |
08/01/2018
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Outcome |
Risk minimisation measures
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All documents
Procedure started
Zinbryta Article-20 referral - PRAC list of questions (PDF/73.41 KB)
First published: 09/06/2017
Last updated: 09/06/2017
EMA/PRAC/366034/2017
Zinbryta Article-20 referral - Timetable for the procedure (PDF/72.42 KB)
First published: 09/06/2017
Last updated: 04/09/2017
EMA/PRAC/366037/2017
Zinbryta Article-20 referral - Notification (PDF/50.03 KB)
First published: 09/06/2017
Last updated: 09/06/2017
Zinbryta Article-20 referral - Review started (PDF/76.03 KB)
First published: 09/06/2017
Last updated: 09/06/2017
EMA/366148/2017
Under evaluation
Zinbryta Article-20 referral - Assessment report on provisional measures (PDF/171.5 KB)
First published: 19/07/2017
Last updated: 01/09/2017
EMA/453660/2017 Rev. 1
Zinbryta Article-20 referral - Annex IV - Scientific conclusions (PDF/44.21 KB)
First published: 19/07/2017
Last updated: 19/07/2017
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
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
Zinbryta Article-20 referral - PRAC assessment report (PDF/241.57 KB)
First published: 12/01/2018
Last updated: 12/01/2018
EMA/779877/2017
Zinbryta Article-20 referral - PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage (PDF/193.2 KB)
First published: 27/10/2017
Last updated: 27/10/2017
EMEA/H/A-20/1456/C/003862/0010
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
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.
News
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10/11/2017
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10/11/2017
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27/10/2017
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27/10/2017
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07/07/2017
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07/07/2017
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09/06/2017