Dermatology Drugs for Children-U.S. Food and Drug Administration Perspective.

Drug development regulation needs of the pediatric population were not addressed until later in the twentieth century. Because of legislation including the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), clinical trials and data analysis targeting the pediatric population have resulted in drug product labeling. Drug products with pediatric dermatology indications benefit from BPCA, PREA, exclusivity incentives, newer analytical methods, and Food and Drug Administration team review. Although legislation, clinical and pharmacological research, and analytical methods have evolved, problems remain. Collaborative and targeted strategies are needed to allow timely drug labeling for pediatric dermatology populations.

Model-Informed Drug Development Approach Supporting Approval of Adalimumab (HUMIRA) in Adolescent Patients with Hidradenitis Suppurativa: a Regulatory Perspective.

On October 16, 2018, FDA expanded the adalimumab dosing regimen to adolescent hidradenitis suppurativa (HS) patients 12 years and older, weighing at least 30 kg without new clinical data. This approval was mainly supported by the model-informed drug development approach. Population pharmacokinetic simulations suggest body weight-tiered dosing regimens in adolescent patients will achieve similar exposure to adult patients across all weight range. Adalimumab has a well-established, 16-year long-term safety profile in various diseases in adult and pediatric populations. Current data of adalimumab in the pediatric population demonstrate no exposure-response relationship for adverse events. The effectiveness in adolescent patients was extrapolated from two adequate and well-controlled phase 3 studies in adult patients, assuming similar positive exposure-efficacy relationships in adults and adolescents. This article provides the insight of the application of MIDD on the adalimumab approval in adolescent HS patients and its implication on drug development and regulatory decision especially for pediatrics or rare diseases.

Case reports: selected dermatoses in children of color.

Three conditions, erythema dyschromicum perstans (EDP), granulomatous periorificial dermatitis (GPD), and Kawasaki disease (KD) are seen more frequently in children of color. EDP and GPD are benign and self-limited dermatoses; therapy can shorten the course of the diseases. KD, a systemic vasculitis, can have life threatening cardiac consequences and timely therapy is essential. In all 3 conditions, clinicians should proceed with prompt and appropriate evaluation, diagnosis, and intervention when indicated. A case representing each condition is presented, followed by a discussion,

Impetigo in pediatrics.

Impetigo is a common skin infection in children. If not treated promptly, it can spread rapidly through a student population and become a significant health problem. Whereas uncomplicated, localized lesions typically are treated with topical mupirocin, widespread infections involving multiple pathogens require systemic treatment with a cephalosporin or a beta-lactamase-resistant antibiotic.