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The development of pharmacological treatment of obesity in children

A European regulatory perspective

Die Entwicklung von Medikamenten für die Behandlung von Adipositas bei Kindern

Eine europäisch-regulatorische Sichtweise

  • Leitthema
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Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz Aims and scope

Abstract

Childhood obesity is recognized by the World Health Organization as one of the most serious public health challenges of the 21st century. Current treatment recommendations consider the role of pharmacotherapy in the treatment of childhood obesity, as an adjunct to lifestyle modifications. This article focuses on key requirements for paediatric development of medicines for obesity in Europe with reference to the European Medicines Agency guideline and a review of Paediatric Investigation Plans (PIP) submitted for this condition, under Regulation (EC) No. 1901/2006 on medicines for paediatric use. To date the European Medicines Agency (EMA) received four paediatric investigation plans for childhood obesity. Issues encountered during the assessment of paediatric investigation plans were all related to the characteristics of the patient population, trial design, choice of endpoints, and safety aspects. Although the number of paediatric investigation plans submitted to the European Medicines Agency thus far is limited, current experience highlights the need for clinical trial protocols that are in line with the specific European guideline. Divergent approaches should be discussed with regulatory authorities before paediatric trials are initiated and included in paediatric investigation plans.

Zusammenfassung

Für die Weltgesundheitsorganisation ist Adipositas bei Kindern eine der größten gesundheitspolitischen Herausforderungen des 21. Jahrhunderts. Aktuelle Therapieempfehlungen sehen die Rolle der medikamentösen Behandlung von Adipositas bei Kindern als Ergänzung zu einer Lebensstilveränderung. Der vorliegende Beitrag beschreibt die wichtigsten Anforderungen an die Entwicklung von Arzneimitteln für Adipositas bei Kindern in Europa und die bisherige Erfahrung mit diesbezüglichen pädiatrischen Prüfkonzepten gemäß der europäischen Verordnung für Kinderarzneimittel (EC) No 1901/2006. Die meisten Probleme bei der Beurteilung der vier bisher eingereichten pädiatrischen Prüfkonzepte betreffen das Design der klinischen Studien, Merkmale der Patientenpopulation, die Wahl der Endpunkte und Sicherheitsaspekte. Obwohl die Zahl der pädiatrischen Prüfkonzepte, die der Europäischen Arzneimittelagentur (EMA) bisher vorgelegt wurden, begrenzt ist, weisen erste Erfahrungen darauf hin, dass die klinischen Studienprotokolle im Einklang mit der dafür bestimmten europäischen Richtlinie stehen sollten. Abweichende Ansätze sollten mit den regulierenden Behörden besprochen werden, bevor pädiatrische Studien initiiert und in pädiatrische Prüfkonzepte aufgenommen werden.

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Acknowledgments

The authors would like to thank M. Carr and S. Aarum for helpful comments on the manuscript. The authors acknowledged that this article reflects the work done in particular by the Paediatric Committee and the Paediatric Team at the EMA.

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The corresponding author states that there are no conflicts of interest.

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  1. Human Medicines Special Areas, European Medicines Agency, 7 Westferry Circus, E14 4HB, Canary Wharf, London, UK

    J. Karres, P. Tomasi & A. Saint Raymond

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  1. J. Karres
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  2. P. Tomasi
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  3. A. Saint Raymond
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Correspondence to J. Karres.

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Disclaimer: The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

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Karres, J., Tomasi, P. & Saint Raymond, A. The development of pharmacological treatment of obesity in children. Bundesgesundheitsbl. 54, 570–576 (2011). https://doi.org/10.1007/s00103-011-1271-8

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  • DOI: https://doi.org/10.1007/s00103-011-1271-8

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