In a move that addresses an unmet medical need Incyteannounced that the U.S. Food and Drug Administration (FDA) has approved Opzelura (ruxolitinib) cream for use in children ages 2 to 11 with mild to moderate atopic dermatitis (AD), a chronic immune-mediated skin disease. This approval marks a significant milestone as Opzelura becomes the first topical Janus kinase (JAK) inhibitor available in the U.S. for pediatric atopic dermatitis, addressing a critical need for new, non-steroidal treatment options. The decision was based on data from the pivotal Phase 3 TRuE-AD3 trial, which demonstrated that Opzelura treatment resulted in significant efficacy in children, with a safety profile consistent with prior findings and no new safety concerns identified. Specifically, the study met its primary and key secondary endpoints, showing that more patients treated with Opzelura achieved Investigator’s Global Assessment-treatment success (IGA-TS) and a 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8 compared to the non-medicated control cream. announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura (ruxolitinib) cream for use in children ages 2 to 11 with mild to moderate atopic dermatitis (AD), a chronic immune-mediated skin disease. This approval marks a significant milestone as Opzelura becomes the first topical Janus kinase (JAK) inhibitor available in the U.S. for pediatric atopic dermatitis, addressing a critical need for new, non-steroidal treatment options. The decision was based on data from the pivotal Phase 3 TRuE-AD3 trial, which demonstrated that Opzelura treatment resulted in significant efficacy in children, with a safety profile consistent with prior findings and no new safety concerns identified. Specifically, the study met its primary and key secondary endpoints, showing that more patients treated with Opzelura achieved Investigator’s Global Assessment-treatment success (IGA-TS) and a 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8 compared to the non-medicated control cream.

This new indication is the third U.S. approval for Opzelura, which is already approved for mild to moderate AD in non-immunocompromised patients 12 years of age and older, as well as for nonsegmental vitiligo in patients 12 years of age and older. The expanded approval offers a much-needed, steroid-free topical treatment option for younger children and their families, with the potential to improve the burdensome symptoms of atopic dermatitis. Both medical experts and parents have expressed enthusiasm for this new therapy, noting the challenges and limited options previously available for pediatric patients. For families with children living with AD, this new treatment provides hope for real relief and an improved quality of life. Incyte has also established a patient support program, Opzelura On Trac, to help eligible patients and their families access the medication and necessary resources. As with all medications, Opzelura has important safety information and potential side effects, including an increased risk of serious infections, cancer, major cardiovascular events, and blood clots, which healthcare providers should discuss with patients and their families.