Genotropin - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure for Genotropin and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a change to the marketing authorisation for Genotropin to include a new indication for the treatment of stunted growth caused by the long-term use of steroids in children with juvenile idiopathic arthritis. The Committee concluded that the change to the marketing authorisation cannot be granted.

What is Genotropin?

Genotropin is a medicine that contains somatropin, which is a copy of natural growth hormone. Growth hormone promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and carbohydrates. Genotropin is used as replacement therapy in children and adults who have a growth hormone deficiency. It is also used to correct short height in children who have the genetic diseases Turner syndrome and Prader Willi syndrome, and in children who have long-standing kidney problems. Somatropin is produced by a method known as 'recombinant DNA technology': it is made by an organism that has received a gene (DNA), which makes it able to produce growth hormone.

Genotropin, also marketed under the trade name Genotonorm, is available throughout the European Union (EU). The company that makes the medicine is Pfizer.

Why was Genotropin reviewed?

In 15 Member States of the EU, Genotropin is authorised under a mutual recognition procedure on the basis of the initial authorisation granted by Denmark on 7 May 19871. In July 2008, Pfizer applied for a change (variation) to the marketing authorisation to add a new indication in Denmark (the 'reference Member State'). This variation was to be recognised in Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom (the 'concerned Member States'). The new indication was the use of Genotropin in children on long-term treatment with steroids for juvenile idiopathic arthritis (JIA), a rare childhood disease causing inflammation of many joints. Genotropin was to be used to improve growth and body composition in children with severe JIA in whom the prolonged use of steroids to help control inflammation had led to a slowing down of growth. Because the Member States were not able to reach an agreement, the Netherlands referred the matter to the CHMP for arbitration on 28 October 2009.

The grounds for the referral were that fewer patients currently need to use steroids than in the past, because other medicines that do not affect growth have become available to control JIA. Another point was the fact that the company had presented too few data on the final height reached by the patients in the studies.

What are the conclusions of the CHMP?

The Committee looked at the studies presented by the company to support the new indication. It also looked at published information on the use of growth hormone in patients with JIA, and convened a meeting of experts, which included experts both in the treatment of hormonal disorders (endocrinologists) and in the treatment of joint diseases (rheumatologists).

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the variation to the marketing authorisation for Genotropin cannot be approved in Denmark as well as in all concerned Member States.

The European Commission issued a decision on 02 September 2010.

Questions and answers on Genotropin and associated names (somatropin injection)

Reference Number: EMEA/H/A-6(12)/001251

Key facts

About this medicine

• Approved name:
  Genotropin
• International non-proprietary name (INN) or common name:
  somatropin
• Associated names:
  Genotonorm

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/C/A-6(12)/001251
• Type:
  Article 6(12) referrals (prior to January 2010)

  This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation (type II). This referral has been replaced by Article 13 referrals.

Key dates and outcomes

• CHMP opinion date:
  24/06/2010
• EC decision date:
  02/09/2010

All documents

Genotropin - Article 6(12) referral - Annex I, II

Adopted

Questions and answers on Genotropin and associated names (somatropin injection)

Reference Number: EMEA/H/A-6(12)/001251

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.