WILMINGTON, DE — Incyte (Nasdaq: INCY) announced that the U.S. Food and Drug Administration has approved Opzelura (ruxolitinib) cream 1.5% for children as young as two with mild to moderate atopic dermatitis whose disease is not adequately controlled with standard topical therapies.
Opzelura becomes the first topical Janus kinase (JAK) inhibitor cleared in the U.S. for pediatric use in atopic dermatitis. The expanded indication builds on earlier approvals for older patients with atopic dermatitis and for individuals 12 and older with nonsegmental vitiligo.
The approval was supported by data from the Phase 3 TRuE-AD3 trial, which showed significantly higher treatment success rates among children using Opzelura compared with a non-medicated cream. Secondary endpoints, including 75% improvement in the Eczema Area and Severity Index (EASI75), were also achieved. Safety findings were consistent with previous trials, with no new concerns identified.
“With this approval, we are now able to offer younger children with atopic dermatitis and their families a much-needed, steroid-free topical treatment option,” said Incyte CEO Bill Meury.
Atopic dermatitis, the most common form of eczema, affects an estimated 2 to 3 million U.S. children ages 2 to 11. Symptoms can include persistent redness, irritation, and heightened vulnerability to skin infections.
Dr. Peter Lio of Northwestern University Feinberg School of Medicine said the approval represents “a meaningful step forward” in addressing limited pediatric options for the chronic disease. Patient advocates and families echoed the significance, noting the new treatment expands choices for managing a condition that often disrupts daily life.
First approved in 2021 for older patients with atopic dermatitis, Opzelura’s latest label expansion reinforces Incyte’s push to broaden treatment options across age groups for chronic immune-mediated skin diseases.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.