Alcover and associated names - referral

Current status

European Commission final decision

Overview

Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg)

Outcome of re-examination of procedure under Article 29(4) of Directive 2001/83/EC

On 22 June 2017, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Alcover granules. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Alcover granules do not outweigh their risks, and the marketing authorisation cannot be granted in Austria or in the following Member States of the EU: Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom.

The company requested a re-examination of the initial opinion. After reviewing the grounds for this request, the CHMP re-examined the opinion and confirmed on 12 October 2017 that the marketing authorisation cannot be granted.

What is Alcover granules?

Alcover granules are a medicine that was expected to be used to treat acute alcohol withdrawal syndrome and to support medium to long-term abstinence in alcohol-dependent adults with a very high level of alcohol consumption. The active substance in Alcover granules, sodium oxybate, attaches to receptors (targets) on nerve cells of the brain and spinal cord for a substance called gamma-aminobutyric acid (GABA), leading to a calming of the activity of these cells. Since it targets these receptors in the same way as alcohol, Alcover granules were to be used to treat the effects of stopping alcohol use in alcohol-dependent patients, including agitation, tremor (shaking) and problems sleeping, and to support continued abstinence.

Alcover syrup is available in Austria and Italy.

Why were Alcover granules reviewed?

Debrégeas & Associés Pharma submitted a marketing authorisation application for Alcover granules to the Austrian medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the 'reference Member State', in this instance Austria) assesses a medicine with a view to granting a marketing authorisation that will be valid nationally as well as in other Member States (the 'concerned Member States', in this instance Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom).

However, the Member States were not able to reach an agreement and the Austrian medicines regulatory agency referred the matter to the CHMP for arbitration on 22 December 2016.

The grounds for the referral were concerns raised by several Member States that the benefits of Alcover granules had not been clearly demonstrated and there are various risks including the risk of dependence, misuse and side effects.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted in support of the marketing authorisation application for Alcover granules are insufficient and of inadequate quality to demonstrate that the medicine is effective in the proposed uses. Risk minimisation measures were proposed for the known risks. However, the CHMP concluded that, since the benefits of Alcover granules had not been clearly demonstrated, the marketing authorisation cannot be granted in the reference and concerned Member States.

After re-examination, the CHMP confirmed its initial opinion that the marketing authorisation could not be granted. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 18/12/2017.

This decision only concerns the marketing authorisation application for Alcover granules and does not affect Alcover syrup.

Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg)

Reference Number: EMA/391578/2017 Rev.1

Key facts

About this medicine

• Approved name:
  Alcover and associated names
• International non-proprietary name (INN) or common name:
  sodium oxybate
• Associated names:
  n/a
• Class:
  -

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29(4)/1451
• Type:
  Article 29(4) referrals

  This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  26/01/2017
• EC decision date:
  18/12/2017

All documents

Opinion provided by Committee for Medicinal Products for human Use

Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg)

Reference Number: EMA/391578/2017 Rev.1

European Commission final decision

Alcover Article-29(4) referral - Annex I

Alcover Article-29(4) referral - Annex II

Alcover Article-29(4) referral - Assessment report

AdoptedReference Number: EMA/833636/2017

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.