FDA advisory committee: Severe need for pediatric studies in AD

An FDA advisory committee agreed there is an unmet medical need for systemic products, drugs, and biologics, along with additional clinical studies, for the treatment of children with atopic dermatitis who do not respond adequately to topical therapy.

In a recent hearing, the Dermatologic and Ophthalmic Drugs Advisory Committee addressed a series of questions related to possible future trials, and ages at which children should be included in the studies.

While atopic dermatitis (AD) has not been widely accepted as a serious medical condition by health care professionals, it is known to have a significant impact on quality of life for both children and their parents or caregivers.

According to presented studies, approximately 90% of patients with AD will develop symptoms by age 5 years, highlighting the need to develop treatments in younger populations. However, prior studies have demonstrated that typical treatments, including topical corticosteroids, have inadequate effectiveness in patients with moderate-to-severe AD and long-term use has been linked with significant adverse events.

Committee members discussed that the initiation of pediatric studies of systemic therapies for AD relies on the specific treatment, the severity of disease being treated, and safety considerations in this demographic compared with the efficacy and safety of available alternative treatments.

Lawrence F. Eichenfield

“There is a window of opportunity,” John J. DiGiovanna, MD, a temporary committee member and staff clinician at the dermatology branch of the National Cancer Institute, said. “One would want to start as early as possible [in age] when it is feasible.”

The committee recommended that the appropriate pediatric population in which to study novel systemic treatments would be among patients with moderate to severe disease, aged 6 months and older, who were resistant to previous treatments.

“Given the high unmet need for effective and safe therapies in atopic dermatitis in children, pediatric studies with systemic therapies should be initiated as soon as possible in the drug development process, as long as there are no safety signals that would raise particular concern in pediatric age patients,” Lawrence F. Eichenfield, MD, a member of the Infectious Diseases in Children Editorial Board and chief of pediatric and adolescent dermatology at Rady Children’s Hospital San Diego, said.