Valebo and associated names - referral

Current status

European Commission final decision

Overview

On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Valebo. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Valebo outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: Austria, Belgium, Bulgaria, Denmark, France, Hungary, Ireland, the Netherlands, Portugal, Slovakia, Slovenia, Spain and the United Kingdom.

What is Valebo?

Valebo is a combination of tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol. It is to be used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.

Alendronic acid is a bisphosphonate that has been used for osteoporosis since the mid-1990s. It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. Blocking the action of these cells leads to less bone loss.

Alfacalcidol is a type of vitamin D (a 'vitamin D analogue'), which is required for calcium absorption and normal bone formation. Alfacalcidol has been used for many years in women who have been through the menopause.

Why was Valebo reviewed?

TEVA Pharma B.V. submitted Valebo to the German medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the 'reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the 'concerned Member States', in this instance Austria, Belgium, Bulgaria, Denmark, France, Hungary, Ireland, the Netherlands, Portugal, Slovakia, Slovenia, Spain and the United Kingdom).

However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 28 February.

The grounds for the referral was a concern raised by Spain that appropriate data had not been submitted to support a statement which was to be included in the indication for Valebo (in section 4.1 of the summary of product characteristics) that alfacalcidol reduces the rate of falls in older people.

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 Valebo should be granted marketing authorisation in all concerned Member States for the treatment of postmenopausal women with osteoporosis. However, although alfacalcidol has been shown in some clinical studies to reduce the risk of falls in older people, the Committee considered that this information should be included under section 5.1 of the summary of product characteristics (and not in section 4.1).

The European Commission issued a decision on 10 March 2014.

Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol)

Reference Number: EMA/793424/2013

Key facts

About this medicine

• Approved name:
  Valebo and associated names
• International non-proprietary name (INN) or common name:
  • alendronic acid
  • alfacalcidol
• Associated names:
  • Tevabone
  • Teboneva

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1364
• 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:
  19/12/2013
• EC decision date:
  10/03/2014

All documents

European Commission final decision

Valebo and associated names Article-29(4) referral - Annex I

Valebo and associated names Article-29(4) referral - Annex II

Valebo and associated names Article-29(4) referral - Assessment report

Valebo and associated names Article-29(4) referral - Annex III

Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol)

Reference Number: EMA/793424/2013

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.