Protelos and Osseor

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision

Table of contents

Current status
European Commission final decision

Overview

Protelos/Osseor to remain available but with further restrictions

The European Medicines Agency has concluded its review of Protelos/Osseor and has recommended further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis. In addition these patients should continue to be evaluated regularly by their doctor and treatment should be stopped if patients develop heart or circulatory problems, such as uncontrolled high blood pressure or angina. As recommended in a previous review, patients who have a history of certain heart or circulatory problems, such as stroke and heart attack, must not use the medicine.

These final recommendations from the Agency's Committee for Medicinal Products for Human Use (CHMP) come after initial advice from the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend the medicine due to its cardiovascular risk.

'The CHMP agreed with the PRAC's overall assessment of the risks of Protelos/Osseor. Both committees worked in close collaboration and the PRAC's recommendation was instrumental for us to fully assess the benefit-risk profile of the medicine', said Tomas Salmonson, chair of the CHMP. 'However, the CHMP considered that, for patients who have no alternative treatment, regular screening and monitoring to exclude cardiovascular disease will sufficiently reduce the risk identified by the PRAC so that these patients can continue to have access to the medicine.'

In arriving at its conclusions, the CHMP noted that study data showed a beneficial effect in preventing fractures, including in patients at high risk of fracture. In addition, available data do not show evidence of an increased cardiovascular risk with Protelos/Osseor in patients who did not have a history of heart or circulatory problems.

The CHMP considered that the cardiovascular risk in patients taking Protelos/Osseor can be managed by restricting its use to patients with no history of heart and circulatory problems and limiting its use to those who cannot take other medicines approved for the treatment of osteoporosis. In addition, patients treated with Protelos/Osseor should be screened and monitored regularly, every 6 to 12 months.

Additional risk minimisation measures include providing educational material to prescribers to ensure that only the appropriate patients are treated with the medicine. Importantly, the company is required to conduct further research to demonstrate the effectiveness of the new measures. The Committee concluded that given the benefits seen in preventing fractures in patients at high risk, Protelos/Osseor should remain an option for patients with no history of cardiovascular disease who cannot take other medicines.

In deciding on how Protelos/Osseor should be used, the CHMP took into account the PRAC's analysis of its benefits and risks as well as advice from osteoporosis experts that there is a group of patients who could benefit from the medicine.

'The PRAC has worked closely with the CHMP throughout the procedure and while we acknowledge that the recommendations of the two committees differed, our understanding of the medicine's benefit-risk profile is closely aligned and we share a common view of the importance of effective monitoring of cardiovascular risk', said June Raine, chair of the PRAC. 'The PRAC will continue to monitor the safety of Protelos /Osseor and the effectiveness of risk minimisation in long term use.'

The CHMP's recommendations were sent to the European Commission, which endorsed them and issued a final legally binding decision valid throughout the EU.

Key facts

About this medicine
Approved name
Protelos and Osseor
International non-proprietary name (INN) or common name
strontium ranelate
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A20/1371/C/00560-561/0039-0034
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.
Authorisation model
Centrally authorised product(s)
Decision making model
PRAC-CHMP-EC
Key dates and outcomes
Procedure start date
16/05/2013
PRAC recommendation date
09/01/2014
CHMP opinion/CMDh position date
20/02/2014
EC decision date
15/04/2014
Outcome
Variation

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

    Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions (PDF/90.27 KB)


    First published: 18/09/2014
    Last updated: 18/09/2014

  • List item

    Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions (PDF/90.27 KB)


    First published: 18/09/2014
    Last updated: 18/09/2014

  • List item

    Protelos Article-20 procedure - Product information (PDF/360.92 KB)


    First published: 18/09/2014
    Last updated: 18/09/2014

  • List item

    Osseor Article-20 procedure - Product information (PDF/375.03 KB)


    First published: 18/09/2014
    Last updated: 18/09/2014

  • List item

    Protelos and Osseor Article-20 procedure - Annex IV (PDF/82.59 KB)


    First published: 18/09/2014
    Last updated: 18/09/2014

    • 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.

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