Tredaptive, Pelzont and Trevaclyn

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview


Tredaptive, Pelzont and Trevaclyn suspended across the EU

Doctors should no longer prescribe these medicines and should review patients' treatment options

On 17 January 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed the recommendation to suspend the marketing authorisations of Tredaptive, Pelzont and Trevaclyn (nicotinic acid / laropiprant) used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol). The CHMP opinion was based on a recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend these medicines.

The CHMP encouraged patients currently taking these medicines to make a non-urgent appointment with their doctor to discuss their treatment. Doctors should no longer prescribe Tredaptive, Pelzont or Trevaclyn and should review patients' treatment options.

The review of Tredaptive, Pelzont and Trevaclyn was initiated in December 2012 after new data from a large, long-term study called HPS2-THRIVE became available. The results of the study, which are still preliminary, indicated that taking nicotinic acid / laropiprant together with a statin has no significant additional benefit in reducing the risk of major vascular events such as heart attack and stroke, compared with statin therapy alone. In addition, a higher frequency of non-fatal but serious side effects was seen in patients taking these medicines.

Having reviewed the results of the study, the CHMP concluded that the benefits of Tredaptive, Pelzont and Trevaclyn no longer outweigh the risks and that their marketing authorisations should be suspended.

More information on the HPS2-THRIVE study is available below.

The CHMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 22 March 2013.

Key facts

About this medicine
Approved name
Tredaptive, Pelzont and Trevaclyn
International non-proprietary name (INN) or common name
laropiprant / nicotinic acid
Class
cardiovascular
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/C/889/A20/37, EMEA/H/C/903/A20/38, EMEA/H/C/897/A20/38
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
Authorisation model
Centrally authorised product(s)
Key dates and outcomes
Procedure start date
20/12/2012
PRAC recommendation date
10/01/2013
EC decision date
22/03/2013
Outcome
Suspension

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • List item

    Tredaptive, Pelzont and Trevaclyn suspended across the EU (PDF/85.72 KB)


    First published: 02/12/2013
    Last updated: 02/12/2013
    EMA/402540/2013

  • List item

    Tredaptive, Pelzont and Trevaclyn suspended across the EU (PDF/85.72 KB)


    First published: 02/12/2013
    Last updated: 02/12/2013
    EMA/402540/2013

  • 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

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