Reacting to FDA Approval of Ruxolitinib for Pediatric Atopic Dermatitis, with Amy Paller, MD

On September 18, 2025, the US Food and Drug Administration (FDA) approval of ruxolitinib cream was announced for pediatric patients 2 years of age and older with atopic dermatitis, providing a new therapeutic option in the treatment armamentarium for those with the disease.1

To address the significance of this decision by the FDA, the HCPLive editorial team spoke with Amy S. Paller, MD, chair of the department of dermatology, director of Skin Biology and Diseases Resource-Based Center, and a Walter J. Hamlin Professor of Dermatology at Northwestern University’s Feinberg School of Medicine. Paller was asked about her hopes for the approval’s impact on pediatric patients.

“We've been really fortunate to see 3 new topicals coming out within the last few years, including getting it down to 2 years of age,” Paller explained. “So I'm delighted to see ruxolitinib joining the recent availability of tapinarof down to 2 years of age, and soon to be roflumilast down to 2 years of age. We'll really have some choices now for our families, particularly in more sensitive areas where we may not want to be using a topical corticosteroid. I think the next question is going to be, when are we going to get more under the age of 2, where we have many very young children who have atopic dermatitis, including in sensitive areas.”

Paller highlighted that for such patients, there has yet to be an FDA approval for a drug outside of crisaborole, which she stated can result in stinging and burning among many such patients.

Paller later connected the approval to the conclusions of her team's research from the PEDISTAD registry, in which the burdens of atopic dermatitis were highlighted among children and their families.2 Paller noted that a high disease burden was seen among children younger than 12 years with inadequately controlled disease at baseline, adding that long-term disease control and newer, safer drugs are needed in this pediatric population.

“Altogether, about 41% of patients were on a systemic medication at the time of enrollment, when these data were collected, so many of them were already being treated,” Paller said. “...When you look at how that was distributed, what was somewhat surprising to me was the large proportion that were on systemic corticosteroids in their history of treatment for atopic dermatitis. That was about 20%, including 18% of those kids who are under 2 years of age, who had received systemic corticosteroids.”

Paller noted that dupilumab had previously been used in only 21% of those under 6 years of age at the time of enrollment, and only in 4% from 0 to 2 years of age.

“But it was primarily the corticosteroids that these kids were being treated with, and I think that's an important point to make,” Paller explained. “I hope that really changes with time.”

For additional information on the significance of the FDA’s approval of ruxolitinib cream for atopic dermatitis in pediatric patients, view Paller’s full video response posted above.

The quotes contained in this summary were edited for the purposes of clarity

References

1. Incytye. Incyte Announces Additional FDA Approval of Opzelura® (Ruxolitinib) Cream in Children Ages 2-11 with Atopic Dermatitis. September 18, 2025. Accessed September 18, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-additional-fda-approval-opzelurar-ruxolitinib

2. Paller A. Atopic Dermatitis Burden Among Families of Children Under 6 Years, with Amy S. Paller, MD. HCPLive. June 11, 2025. https://www.hcplive.com/view/atopic-dermatitis-burden-among-families-children-under-6-years-amy-s-paller-md.