Protelos and Osseor

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

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally authorised product(s)
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

  • 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

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