John Browning, MD, reacts to the approval of ruxolitinib for atopic dermatitis in children

On September 18, 2025, the FDA approved ruxolitinib to treat atopic dermatitis in patients aged 2 to 11 years.^1,2

In this brief reaction video, John Browning, MD, Chief of Dermatology at Children’s Hospital of San Antonio and Organon Health Partner, explained the excitement surrounding another steroid-free atopic dermatitis treatment tool.

"I think it is very exciting to have another non-steroidal approved for kids with atopic dermatitis. [Ruxolitinib] has been approved in kids aged 12 years and older for vitiligo for some time now, so I do think that it is good to have multiple products approved that allow multiple options in treating atopic dermatitis," he said.

Ruxolitinib's expanded approval was based on data from the phase 3 TRuE-AD3 study (NCT04921969), a randomized, double-blind, vehicle-controlled trial that evaluated the safety and efficacy of the topical vs vehicle in children with atopic dermatitis aged 2 to younger than 12 years. The trial featured more than 300 patients who had an atopic dermatitis diagnosis for at least 3 months.¹

The trial met its primary endpoint, the proportion of participants achieving an Investigator’s Global Assessment Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at Week 8.

Click here for additional approval details and more phase 3 data for ruxolitinib.

"It's just so great to finally be able to get a 2A non-steroidal medicine as first line, which is what I think it should be," added Browning. "I don't think we should have to make patients try a topical steroid first and [potentially] have a rebound issue... it is just good to finally be able to start with these."

References:

1. Fitch J. FDA approves ruxolitinib for pediatric patients with atopic dermatitis aged 2 to 11 years. June 17, 2025. Accessed September 18, 2025. Contemporary Pediatrics. https://www.contemporarypediatrics.com/view/fda-approves-ruxolitinib-for-pediatric-atopic-dermatitis

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