Norditropin - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure for Norditropin and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a requested change to the marketing authorisation for these medicines to include a new indication for use in children with Prader-Willi syndrome. The Committee concluded that the change to the marketing authorisation cannot be granted.

What is Norditropin?

Norditropin is a medicine that contains somatropin, which is a copy of naturally occurring human growth hormone. Growth hormone promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.

Norditropin is used as replacement therapy in children and adults who have a growth hormone deficiency. It is also used to correct short height in girls who have the genetic disease called Turner syndrome, in children who have long-standing kidney problems, and in children born small for their gestational age and who have not caught up by the age of four.

The somatropin in Norditropin is produced by a method known as 'recombinant DNA technology': it is made by an organism that has received a gene (DNA), which makes the organism able to produce it.

Norditropin is marketed in the European Union Member States under the names Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx and associated names. The company that makes the medicine is NovoNordisk.

Why was Norditropin reviewed?

Norditropin is authorised under a mutual recognition procedure based on an initial authorisation granted by Denmark. In May 2010, the company applied for an additional indication in Denmark and in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom¹. The new indication was for the use of Norditropin in children with Prader-Willi syndrome, a rare genetic disease that affects children's growth and development. Although somatropin medicines are already approved in EU Member States for use in Prader-Willi syndrome, the Member States were unable to reach agreement on whether to accept this indication for Norditropin. On 20 April 2011, Denmark referred the matter to the CHMP for arbitration.

The grounds for the referral were the concerns of some Member States that the data on Norditropin submitted in the application were not sufficient to demonstrate its effectiveness in Prader-Willi syndrome. The Member States cited methodological weaknesses in the study presented, the wide range of doses used and insufficient data (e.g. missing data on body composition measurements).

¹ In May 2011 the marketing authorisations of the concerned products were withdrawn in Estonia, and in June 2011 the marketing authorisations of the concerned products were withdrawn in Latvia.

What are the conclusions of the CHMP?

The Committee looked at the study presented by the company to support the new indication.

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that the data were insufficient and that the study presented, which was an observational study, did not meet required methodological standards. The CHMP therefore recommended that the new indication for Norditropin and associated names should not be granted in Denmark or in the concerned Member States.

The European Commission issued a decision on 6 March 2012.

Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection)

Adopted Reference Number: EMA/CHMP/966954/2011 Summary:

The European Medicines Agency has completed an arbitration procedure for Norditropin and associated names.

Key facts

About this medicine

• Approved name:
  Norditropin
• International non-proprietary name (INN) or common name:
  somatropin
• Associated names:
  • Norditropin FlexPro
  • Norditropin NordiFlex
  • Norditropin SimpleXx

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-13/1304
• Type:
  Article 13 referrals

  This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II), on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  15/12/2011
• EC decision date:
  06/03/2012

All documents

Norditropin - Article 13 referral - Assessment Report

Reference Number: EMA/171189/2012

Norditropin - Article 13 referral - Annex I

Norditropin - Article 13 referral - Annex II

Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection)

Adopted Reference Number: EMA/CHMP/966954/2011 Summary:

The European Medicines Agency has completed an arbitration procedure for Norditropin and associated names.

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.