FDA approves Opzelura for atopic dermatitis in children

The U.S. Food and Drug Administration has approved Opzelura cream 1.5% (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. 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 ≥75% 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.

“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.”

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