Zinbryta - referral

Current status

European Commission final decision

Overview

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 Zinbryta Article-20 procedure - Multiple sclerosis medicine Zinbryta suspended in the EU.

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 On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine.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.

Zinbryta Article-20 procedure - EMA review of Zinbryta confirms medicine’s risks outweigh its benefits

Reference Number: EMA/286850/2018

Key facts

About this medicine

• Approved name:
  Zinbryta
• Associated names:
  Zinbryta

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-20/1462/C/003862/0018
• 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)
• Decision making model:
  PRAC-CHMP-EC

Key dates and outcomes

• Procedure start date:
  02/03/2018
• PRAC recommendation date:
  17/05/2018
• EC decision date:
  27/03/2018
• Outcome:
  Suspension

All documents

Procedure started

Zinbryta Article-20 procedure - PRAC list of questions

Zinbryta Article-20 procedure - Timetable for the procedure

Zinbryta Article-20 procedure - Notification

Zinbryta Article-20 procedure - Review started

Reference Number: EMA/120379/2018

Under evaluation

Zinbryta Article-20 procedure - Scientific conclusions

Zinbryta Article-20 procedure - Assessment report on provisional measures

Reference Number: EMA/159031/2018

Zinbryta Article-20 procedure - Multiple sclerosis medicine Zinbryta suspended in the EU

Reference Number: EMA/134289/2018

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Zinbryta Article-20 procedure - EMA review of Zinbryta confirms medicine’s risks outweigh its benefits

Reference Number: EMA/286850/2018

European Commission final decision

Zinbryta Article-20 referral - PRAC assessment report

AdoptedReference Number: EMA/377140/2018

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.