It is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b>
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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).<\/p>\n
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.<\/p>\n
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. The primary end point was met, with significantly more patients treated with Opzelura achieving Investigator’s Global Assessment-treatment success versus patients treated with vehicle control cream. The trial also met the secondary end point of more Opzelura-treated patients demonstrating \u226575 percent improvement in the Eczema Area and Severity Index at week 8 versus control. No new safety signals were observed, with the most common adverse reaction being upper respiratory tract infection.<\/p>\n
“Navigating a complex condition like atopic dermatitis can be very challenging for children,” Peter Lio, M.D., from the Northwestern University Feinberg School of Medicine in Chicago, said in a statement. “With this approval, we now have a new, nonsteroidal topical option that expands how we care for kids with this chronic disease.”<\/p>\n
Approval of Opzelura was granted to Incyte.<\/p>\n