MONDAY, Sept. 29, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Opzelura cream 1.5 percent (ruxolitinib) for children ages 2 to 11 years with atopic dermatitis (AD).

The approval is the first topical Janus kinase (JAK) inhibitor for the short-term, noncontinuous chronic treatment of mild-to-moderate AD in nonimmunocompromised children (age 2 years and older) whose disease is not well controlled with topical prescription therapies or when topical therapies are not recommended.

The approval is based on results from the phase 3 TRuE-AD3 trial, which evaluated the safety and efficacy of Opzelura cream in children ages 2 to <12 years with AD>

“Navigating a complex condition like atopic dermatitis can be very challenging for children,” Peter Lio, M.D., from the No

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