FDA Approves Opzelura Cream for Atopic Dermatitis in Young Children

The U.S. Food and Drug Administration (FDA) has recently approved the use of Opzelura 1.5% cream (ruxolitinib) for treating children aged 2 to 11 years suffering from atopic dermatitis (AD). This marks a significant advancement as it is the first topical Janus kinase (JAK) inhibitor approved for short-term, noncontinuous management of mild to moderate AD in children who are not immunocompromised. The approval stems from positive results in the Phase 3 TRuE-AD3 clinical trial, which demonstrated the safety and efficacy of Opzelura in pediatric patients. In the trial, more children treated with Opzelura achieved significant treatment success, as measured by Investigator's Global Assessment, compared to those using a placebo. Additionally, a secondary endpoint showed a higher proportion of children experiencing at least a 75% improvement in the Eczema Area and Severity Index (EASI) score at week 8. Importantly, no new safety concerns arose during the trial, with the most common adverse effect being upper respiratory tract infections. According to Dr. Peter Lio of Northwestern University Feinberg School of Medicine, this approval offers a new, nonsteroidal topical option for managing the complex and often challenging condition of atopic dermatitis in children. "This development provides clinicians and families with a valuable tool to better control symptoms and improve quality of life," he said. The approval broadens the therapeutic options available for pediatric patients, especially those whose condition does not respond sufficiently to existing topical treatments.