Substances related to nicotinic acid
- Procedure started
- Under evaluation
- PRAC recommendation
- CMDh position
- European Commission final decision
Table of contents
Overview
Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels
CMDh endorses PRAC recommendation
On 18 December 2013, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)1 confirmed by majority that medicines containing acipimox should have their marketing authorisations amended to ensure that they are used across the European Union only as an additional or alternative treatment in type IIb and type IV hyperlipoproteinaemia. These are conditions involving hypertriglyceridaemia (high levels of triglycerides, a type of fat, in the blood), with or without increased cholesterol. Acipimox-containing medicines should be used when changes in lifestyle, including diet and exercise, and treatment with other medicines are not adequate.
These recommendations were originally made by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 5-8 November 2013. The original reason for the review of acipimox was HPS2-THRIVE, a large study which looked at the long-term effect of the combination of nicotinic acid (a substance related to acipimox) and another medicine, laropiprant, in treating lipid disorders. The study showed that adding this combination to treatment with statins (another class of medicines used to treat lipid disorders) did not lead to additional benefits in reducing the risk of major vascular events such as heart attack and stroke, but did result in a higher frequency of non-fatal but serious side effects. As a result, the European Medicines Agency recommended the suspension of medicines containing the combination of nicotinic acid and laropiprant across the EU2. Because acipimox was related to nicotinic acid and was marketed for lipid disorders in the EU, its benefit-risk balance was also then reviewed.
After looking at the available data on acipimox, including evidence from the literature, spontaneous reports of adverse effects and advice from a group of experts in the treatment of lipid disorders, as well as data from HPS2-THRIVE, the PRAC concluded that acipimox continues to have a role as an additional or alternative treatment to reduce triglycerides in those forms of hyperlipoproteinaemia that involve high triglyceride levels (with or without increased cholesterol), in patients in whom lifestyle changes and use of other medicines such as fibrates and statins are not adequate. The results from HPS2-THRIVE could not be applied directly to acipimox since the study investigated the effect of the combination with laropiprant, whose effects were not established, and possible differences between nicotinic acid and acipimox were also identified. However, findings from the HPS2-THRIVE study were used to expand the warnings in the acipimox product information concerning a possible increased risk of painful muscle damage when acipimox is used together with a statin.
The CMDh endorsed the PRAC recommendations by majority at its meeting of 16-18 December 2013 and its position was sent to the European Commission which endorsed it and issued an EU-wide legally binding decision on 20 February 2014.
Key facts
About this medicine
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Approved name |
Substances related to nicotinic acid
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International non-proprietary name (INN) or common name |
acipimox
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Associated names |
Olbetam
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Class |
Lipid-lowering agents
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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/A-31/1366
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Type | |
Authorisation model |
Nationally authorised product(s)
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Decision making model |
PRAC-CMDh
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Key dates and outcomes
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Procedure start date |
07/03/2013
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PRAC recommendation date |
07/11/2013
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CHMP opinion/CMDh position date |
18/12/2013
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EC decision date |
20/02/2014
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Outcome |
Variation
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All documents
Procedure started
Substances related to nicotinic acid Article-31 referral - Draft Annex I (PDF/79.88 KB)
First published: 08/03/2013
Last updated: 15/08/2013
EMA/148540/2013
Substances related to nicotinic acid Article-31 referral - PRAC list of questions (PDF/62.69 KB)
First published: 08/03/2013
Last updated: 08/03/2013
EMA/PRAC/138313/2013
Substances related to nicotinic acid Article-31 referral - Notification (PDF/200.63 KB)
First published: 08/03/2013
Last updated: 08/03/2013
Substances related to nicotinic acid Article-31 referral - Review started (PDF/73.97 KB)
First published: 08/03/2013
Last updated: 15/08/2013
EMA/136363/2013
Substances related to nicotinic acid Article-31 referral - Timetable for the procedure (PDF/65.49 KB)
First published: 08/03/2013
Last updated: 11/10/2013
EMA/PRAC/138312/2013
Position provided by CMDh
Substances related to nicotinic acid Article-31 referral - Annex III (PDF/15.03 KB)
First published: 20/12/2013
Last updated: 20/12/2013
Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels (PDF/82.61 KB)
First published: 20/12/2013
Last updated: 20/12/2013
EMA/779546/2013
European Commission final decision
Substances related to nicotinic acid Article-31 referral - Annex I (PDF/37.26 KB)
First published: 13/03/2014
Last updated: 13/03/2014
Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels (PDF/83.76 KB)
First published: 13/03/2014
Last updated: 13/03/2014
EMA/108603/2014
Substances related to nicotinic acid Article-31 referral - Annex II (PDF/43.15 KB)
First published: 13/03/2014
Last updated: 13/03/2014
Substances related to nicotinic acid Article-31 referral - Annex III (PDF/34.76 KB)
First published: 13/03/2014
Last updated: 13/03/2014
Substances related to nicotinic acid Article-31 referral - Assessment report (PDF/169.92 KB)
First published: 13/03/2014
Last updated: 13/03/2014
EMA/PRAC/18751/2014
Substances related to nicotinic acid Article-31 referral - CMDh divergent position (PDF/21.36 KB)
First published: 13/03/2014
Last updated: 13/03/2014
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.