Zinbryta

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Summary

EMA review of Zinbryta confirms medicine’s risks outweigh its benefits

Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the multiple sclerosis medicine Zinbryta (daclizumab beta) poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.

Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected. The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.

Healthcare professionals should continue monitoring patients who have been treated with Zinbryta in line with recommendations issued in March 2018.

There are no immediate consequences of the PRAC’s review as Zinbryta is no longer authorised in the EU. On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine. Zinbryta is no longer available in hospitals and pharmacies in the EU.

A full assessment report on the review will be published shortly.

More about the medicine

Zinbryta is a medicine that was authorised in 2016 for treating relapsing forms of multiple sclerosis. To date over 10,000 patients have been treated with Zinbryta worldwide. The majority of EU patients have been treated in Germany.

More about the procedure

The review of Zinbryta was initiated following a request from the European Commission on 26 February 2018, under Article 20 of Regulation (EC) No 726/2004.

On 6 March 2018, while the review was ongoing, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended suspension of the marketing authorisation of Zinbryta and a recall of the product. The European Commission issued a legally binding decision to suspend the marketing authorisation on 8 March 2018.

On 27 March 2018, the European Commission withdrew the marketing authorisation of the medicine at the request of the marketing authorisation holder Biogen Idec Ltd.

The PRAC has now concluded its review of the available evidence on Zinbryta. The PRAC report will be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP).

As the medicine is no longer authorised in the EU no further action will be taken by the European Commission.

Name Language First published Last updated
Zinbryta Article-20 procedure - EMA review of Zinbryta confirms medicine’s risks outweigh its benefits (English only) 2018-05-18  

Key facts

About this medicine

Approved nameZinbryta
International non-proprietary name (INN) or common name

daclizumab

Associated names
Class

About this procedure

Current statusRecommendation provided by Pharmacovigilance Risk Assessment Committee
Reference numberEMEA/H/A-20/1462/C/003862/0018
TypeArticle 20 procedures

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

Decision making modelPRAC-CHMP-EC
Authorisation modelCentrally authorised product(s)

Key dates and outcomes

Procedure start date02/03/2018
PRAC recommendation date17/05/2018
OutcomeSuspension

All documents

Procedure started

Name Language First published Last updated
Zinbryta Article-20 procedure - Timetable for the procedure EN = English 2018-03-09  
Zinbryta Article-20 procedure - Review started EN = English 2018-03-02  
Zinbryta Article-20 procedure - Notification EN = English 2018-03-09  
Zinbryta Article-20 procedure - PRAC list of questions EN = English 2018-03-09  

Under evaluation

Name Language First published Last updated
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Scientific conclusions EN = English 2018-03-14  
Zinbryta Article-20 procedure - Multiple sclerosis medicine Zinbryta suspended in the EU EN = English 2018-03-07 2018-03-14
Zinbryta Article-20 procedure - Assessment report on provisional measures EN = English 2018-03-14  

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Name Language First published Last updated
Zinbryta Article-20 procedure - EMA review of Zinbryta confirms medicine’s risks outweigh its benefits EN = English 2018-05-18  

Document description:

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) or Coordination Group for Mutual Recognition and Decentralised Procedures - Human (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 / CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

Current status:
Recommendation provided by Pharmacovigilance Risk Assessment Committee

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