Atopic Dermatitis: FDA Finalizes Guidance on Timing of Pediatric Studies

Regulatory NewsRegulatory News | 02 October 2018 |  By 

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 study 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.

“Applicants are encouraged to discuss the specifics of pediatric programs as early as is feasible with the division because sponsors generally are required to submit pediatric study plans under section 505B of the Federal Food, Drug, and Cosmetic Act no later than 60 days after an end-of-phase 2 meeting.”

But prior to enrolling pediatric patients, FDA advises sponsors to consider conducting a juvenile animal toxicity study that incorporates appropriate endpoints.

“Considering the effect on the pediatric population of disease-related morbidity, the risk of disease-related progression (e.g., atopic march), and the relative risk-benefit calculus with off-label use of immunosuppressive therapies, it is not generally necessary to have an extensive safety database in adults before initiating pediatric studies,” the guidance adds.

Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs: Guidance for Industry


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