This guidance addresses FDA’s current thinking about the relevant age groups to study and how early in drug development applicants should incorporate pediatric patients for development of systemic drugs for atopic dermatitis (AD). The recommendations in this guidance are based on input received from the March 9, 2015, Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) meeting on this topic and review of medical literature and relevant statutes and regulations.
This guidance does not address the technical aspects of drug development for pediatric patients with AD, which FDA will address in a future guidance.
AD is a chronic pruritic inflammatory skin disease that primarily affects pediatric patients but also occurs in adults. AD is associated with substantial morbidity, including sleep disruption, decreased neurocognitive function, and impaired quality of life for patients and their families. AD is also associated with numerous comorbidities, including cutaneous infections, extracutaneous infections, asthma, rhinitis, food allergies, obesity, and hypertension.
Historically, FDA recommended that applicants provide data on the use of topical drug products in pediatric patients for treatment of AD before initial drug approval. In contrast, FDA did not recommend initiation of pediatric studies for systemic drugs under development for treatment of AD and instead recommended the studies after approval of the drugs for adult use. At the March 9, 2015, meeting, the DODAC recommended that, for systemic drugs for AD, pediatric studies generally should be initiated earlier during development.