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

  • 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.

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