Zinbryta

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Summary

 

EMA reviews multiple sclerosis medicine Zinbryta

Review follows case of fulminant liver failure

The European Medicines Agency (EMA) has started a review of the medicine Zinbryta (daclizumab) used to treat adults with relapsing forms of multiple sclerosis (a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord). The review follows the death from fulminant liver failure of a patient who was treated with Zinbryta in an ongoing observational study, as well as four cases of serious liver injury.

The risk of liver damage with Zinbryta was already known at time of its approval in July 2016, and several measures had been taken to manage this risk, including providing educational materials for healthcare professionals and for patients on how to prevent or reduce liver damage.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now evaluate all available data and determine whether there are any implications for the use of the product and if there is a need to introduce any new measures to minimise this risk.

While the review is ongoing, healthcare professionals using Zinbryta should closely monitor their patients and discuss with them the risk of liver damage and possible symptoms. Patients should contact their doctor promptly should they develop any symptoms of liver problems, such as unexplained nausea, vomiting, abdominal pain, tiredness, loss of appetite, yellowing of the skin and eyes, and dark urine.

More about the medicine

Zinbryta is a medicine used to treat adults with relapsing forms of multiple sclerosis. Multiple sclerosis is a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord. Relapsing means that the patient has flare-ups of the symptoms.

Zinbryta is available as a solution for injection in pre-filled pens and syringes. It is injected under the skin once a month.

Zinbryta contains the active substance daclizumab and was authorised in the EU in July 2016.

More about the procedure

The review of Zinbryta has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.

The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. The PRAC recommendations will then be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion.

The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.

Name Language First published Last updated
Zinbryta Article-20 referral - Review started (English only) 2017-06-09  

Key facts

About this medicine

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

daclizumab

Associated names
Class

About this procedure

Current statusProcedure started
Reference numberEMEA/H/A-20/1456/C/003862/0010
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 date09/06/2017

All documents

Procedure started

Name Language First published Last updated
Zinbryta Article-20 referral - Review started EN = English 2017-06-09  
Zinbryta Article-20 referral - Notification EN = English 2017-06-09  
Zinbryta Article-20 referral - PRAC list of questions EN = English 2017-06-09  
Zinbryta Article-20 referral - Timetable for the procedure EN = English 2017-06-09  

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:
Procedure started