Inductos - referral

Current status

European Commission final decision

Overview

On 22 October 2015, the European Medicines Agency (EMA) recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures. Inductos will remain suspended until issues with the manufacturing site for one of the components of Inductos (an absorbable sponge) are resolved.

EMA started a review of Inductos following an inspection by Dutch and Spanish authorities which found the manufacturing site of the absorbable sponge to be non-compliant with manufacturing requirements. The inspectors noted that the manufacturer, located in the United States, did not have adequate measures in place to prevent particle contamination of the sponges.

Although there is no indication of risk to patients linked to the inspection findings, EMA's Committee for Medicinal Products for Human Use (CHMP) considered that the quality of Inductos cannot be assured with the current manufacturing process. The CHMP therefore concluded that Inductos should be suspended until the manufacturing issues are satisfactorily addressed.

The CHMP recommendation was sent to the European Commission, which endorsed it and issued a final legally binding decision.

Information for patients and healthcare professionals

• Problems have been identified with the way the absorbable sponge in Inductos is manufactured.
• Although there is no indication of risk to patients, Inductos has been suspended and will no longer be available in the EU until issues with the manufacturing site for the absorbable sponge are solved.
• There are alternative treatments available in the EU.
• Patients who have any questions or concerns should speak to their healthcare professional.

More about the medicine

Inductos is available as a kit for implant containing a powder, solvent and absorbable collagen sponge (or matrix). It is used during surgery in patients with damaged spinal discs or leg (tibia) fractures.

The active substance is dibotermin alfa, a protein that acts on the bone structure and helps with the formation of new bone tissue. The new bone tissue grows into the sponge, which is gradually degraded by the body.

Inductos was authorised centrally in the EU in September 2002.

More about the procedure

The review of Inductos was initiated on 23 July 2015 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004. It was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 20/11/2015.

Inductos Article-20 procedure - Inductos to be suspended in the EU

Reference Number: EMA/683814/2015

Key facts

About this medicine

• Approved name:
  Inductos
• International non-proprietary name (INN) or common name:
  dibotermin alfa
• Associated names:
  Inductos

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-20/1422/C/0408/0082
• 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.

Key dates and outcomes

• CHMP opinion date:
  22/10/2015
• EC decision date:
  20/11/2015

All documents

Procedure started

Inductos Article-20 procedure - Review started

AdoptedReference Number: EMA/491454/2015

Inductos Article-20 procedure - CHMP list of questions

AdoptedReference Number: EMA/CHMP/492625/2015

Inductos Article-20 procedure - Notification

Inductos Article-20 procedure – Timetable for the procedure

Opinion provided by Committee for Medicinal Products for human Use

Inductos Article-20 procedure - Inductos to be suspended in the EU

Reference Number: EMA/683814/2015

European Commission final decision

Inductos Article-20 procedure - Assessment report

Reference Number: EMA/746527/2015

Inductos Article-20 procedure - Annex I

Inductos Article-20 procedure - Annex II

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.