A new effort to speed up paediatric drug development and arise awareness on the importance of clinical and pre-clinical paediatric trials has been done by the Food and Drugs Administration (FDA) that published a new draft guidance recommending early, pre-approval trials in pediatrics for systemic dermatitis drugs. This guidance addresses FDA’s current thinking about the relevant age groups to study and how early in a drug’s development pediatric patients should be incorporated during development of systemic drugs for atopic dermatitis (AD). This document provides an important revision of a previous guide released by FDA, recommending the submission of pre-approval data on the use of topical products, but that did not mention the pediatric studies of systemic drugs until after adult approval. This significant revision of the guidelines implies that:
- Sponsors should initiate pediatric studies early in development, typically after obtaining initial evidence from early-phase adult studies
- Juvenile animal toxicity studies should also be considered before enrolling human participants.
- If the preliminary data are approved, Sponsors should provide as much information as possible when labeling in regard to pediatric use
This action represents a first step forward to speed up the process of paediatric drug authorization and incorporate the paediatric population in the drug development process. The inclusion of the paediatric factor in this sense is a key element also in the European regulatory perspectives. In Europe, on 28 February 2018 the European Medicines Agency (EMA) adopted the ICH E11 guideline addendum, requiring consideration of regulatory and scientific advances relevant to pediatric populations. The purpose of this addendum is to complement and provide clarification and current regulatory perspective on topics in pediatric drug development.
The FDA guidelines is available here.
More information about the ICH E11 guideline addendum are available at this link.