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 |
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. |
Decision making model |
PRAC-CHMP-EC
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Authorisation model |
Centrally authorised product(s)
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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
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Zinbryta Article-20 referral - Annex IV (PDF/38.66 KB)
First published: 12/01/2018
Last updated: 12/01/2018
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 - Annex I (PDF/644.26 KB)
First published: 12/01/2018
Last updated: 12/01/2018
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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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