The U.S. Meals and Drug Administration has authorized Opzelura cream 1.5% (ruxolitinib) for kids ages 2 to 11 years with atopic dermatitis (AD).
The approval is the primary topical Janus kinase (JAK) inhibitor for the short-term, noncontinuous continual remedy of mild-to-moderate AD in nonimmunocompromised kids (age 2 years and older) whose illness is just not nicely managed with topical prescription therapies or when topical therapies will not be beneficial.
The approval is predicated on outcomes from the section 3 TRuE-AD3 trial, which evaluated the security and efficacy of Opzelura cream in kids ages 2 to
“Navigating a complex condition like atopic dermatitis can be very challenging for children,” Peter Lio, M.D., from the Northwestern College Feinberg College of Drugs in Chicago, mentioned in an announcement. “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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FDA approves Opzelura for atopic dermatitis in kids (2025, September 29)
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