USA – Atopic Dermatitis: FDA Finalizes Guidance on Timing of Pediatric Studies

The US Food and Drug Administration (FDA) finalized the 3-page guidance to help sponsors understand FDA’s current thinking about the relevant age groups to stuAtopic Dermatitisdy and how early in drug development applicants should incorporate pediatric patients for developing systemic drugs for atopic dermatitis (AD).

The guidance, based on input received from a March 2015 Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) meeting, where the committee recommended that, for systemic drugs for AD, pediatric studies generally should be initiated earlier during development.

“Studies of systemic treatments in pediatric patients with AD should be initiated early in development, typically after obtaining initial evidence of efficacy and safety from early phase studies in adults,” the guidance says…