FDA advisory committee agrees on need for pediatric studies on atopic dermatitis
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.
The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) addressed a series of questions related to possible future trials, and at what ages of children should be included in the studies.
“There is clearly an unmet need,” Lynn A. Drake, MD, chairperson of the DODAC, said in summarizing the committee’s discussion. “It’s time to study children. … We do need to have clinical trial of kids.”
“There is a window of opportunity,” John J. DiGiovanna. MD, a temporary committee member, said, “One would want to start as early as possible [in age] when it is feasible.”
Committee member Mary E. Maloney, MD, said that initial safety data should be reviewed, then the products should be studied in pediatrics as soon as possible.
“We can’t allow the continued deferrals,” she said. “We need to be very proactive in there aren’t deferrals … so kids get a break.”
The physicians discussed that uncertainty of potential risks and benefits of novel agents would depend on the severity of atopic dermatitis in a specific child.
“[If] it’s a child I know well … [then] I consider a systemic agent treatment,” Bernard A. Cohen, MD, a temporary member, said. He added that he would not use systemic corticosteroids in treating children.
“I can’t emphasize enough the need for guidance (documents),” Elaine Siegfried, MD, a temporary member, said.
The committee members discussed that treatment should be stratified by ages, and the need to look at risk-benefit ratio each of age group.
Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego, spoke during the open public hearing section of the meeting, as a representative for Roche-Genentech. He was later asked by the panel to share his viewpoint during the review of questions.
“We should get tough on what we’re calling severe (atopic dermatitis),” Eichenfield said, as he emphasized that children at younger ages often experiencing the most severe form of the disease.
Megha M. Tollefson, MD, a pediatric dermatologist at Mayo Clinic, Rochester, Minn., spoke on behalf of the American Academy of Pediatrics, testifying on the need for the development of safer medications for children.
Two children, aged 17 and 13 years, discussed their experiences with atopic dermatitis for much of their lives, and how it negatively impacted their quality of life.
Industry and FDA representatives also testified at the meeting.
“The most important thing that came out of this meeting is this is on the table now,” Drake said in her conclusion.