Tredaptive, Pelzont and Trevaclyn
- Procedure started
- Under evaluation
- PRAC recommendation
- CHMP opinion
- European Commission final decision
Table of contents
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
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Approved name |
Tredaptive, Pelzont and Trevaclyn
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International non-proprietary name (INN) or common name |
laropiprant / nicotinic acid
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Class |
cardiovascular
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About this procedure
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Current status |
European Commission final decision
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Reference number |
EMEA/H/C/889/A20/37, EMEA/H/C/903/A20/38, EMEA/H/C/897/A20/38
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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
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Authorisation model |
Centrally authorised product(s)
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Key dates and outcomes
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Procedure start date |
20/12/2012
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PRAC recommendation date |
10/01/2013
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EC decision date |
22/03/2013
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Outcome |
Suspension
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All documents
Procedure started
Tredaptive, Pelzont and Trevaclyn Article-20 procedure - Review started (PDF/75.85 KB)
First published: 21/12/2012
Last updated: 21/12/2012
EMA/819878/2012
Tredaptive, Pelzont and Trevaclyn Article-20 procedure - Timetable for the procedure (PDF/75.07 KB)
First published: 21/12/2012
Last updated: 21/12/2012
EMA/PRAC/821171/2012
Tredaptive, Pelzont and Trevaclyn Article-20 procedure - PRAC list of questions (PDF/71.16 KB)
First published: 21/12/2012
Last updated: 21/12/2012
EMA/PRAC/821161/2012
Tredaptive, Pelzont and Trevaclyn Article-20 procedure - Notification (PDF/191.83 KB)
First published: 21/12/2012
Last updated: 21/12/2012
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
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