Incyte’s sNDA for ruxolitinib cream in children ages 2–11 now faces a new action date to allow additional data review.
Incyte announced that the US Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura), a topical Janus kinase inhibitor, for the treatment of children 2-11 years old with mild to moderate atopic dermatitis.
The Prescription Drug User Fee Act action date has been extended by three months to Sept 19, 2025. The FDA extended the date to allow time to review additional chemistry, manufacturing and controls data on the 0.75% strength submitted by Incyte in response to a recent FDA information request, according to a release from Incyte.
“Atopic dermatitis is a chronic immune-mediated skin condition that can be difficult to manage, particularly for the millions of children in the US affected by [atopic dermatitis],” says Steven Stein, MD, chief medical officer at Incyte, in a release. “We are confident in the potential of ruxolitinib cream to become an important non-steroidal, topical treatment option for pediatric patients with atopic dermatitis, and we will continue to work closely with the FDA to ensure the agency has all of the information needed to complete its review.”
Phase 3 Study Shows Positive Results
The sNDA submission for ruxolitinib cream in pediatric atopic dermatitis was based on data from the phase 3 TRuE-AD3 study, which evaluated the safety and efficacy of ruxolitinib cream in children (age ≥2 to <12 years) with atopic dermatitis. The TRuE-AD3 study met its primary endpoint with significantly more patients treated with Opzelura achieving Investigator’s Global Assessment-treatment success, a measure of treatment efficacy, than patients treated with vehicle control (non-medicated cream). In addition, a secondary endpoint of patients demonstrating at least a 75% improvement in the Eczema Area and Severity Index at week eight was also achieved.
The overall safety profile of Opzelura in the TRuE-AD3 trial was consistent with previous data, and no new safety signals were observed. No serious infections, major adverse cardiovascular events, malignancies, or thromboses were reported during the eight-week vehicle-controlled period. The most common treatment-related adverse event among patients treated with Opzelura was application site pain (2.7% vs 0% in vehicle arm). These events were mild and did not lead to treatment interruption.
Opzelura is currently approved by the FDA for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older and for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
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