WILMINGTON, DE — The U.S. Food and Drug Administration (FDA) has announced a three-month extension for its review of the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura®), submitted by Incyte for the treatment of children aged 2-11 with mild to moderate atopic dermatitis (AD). The new action date under the Prescription Drug User Fee Act (PDUFA) is now set for September 19, 2025.
The review extension is to provide additional time for the FDA to evaluate new data submitted by Incyte in response to a request for chemistry, manufacturing, and controls (CMC) information on the 0.75% strength of the cream.
“Atopic dermatitis (AD) is a chronic immune-mediated skin condition that can be difficult to manage, particularly for the millions of children in the U.S. affected by AD,” said Steven Stein, M.D., Chief Medical Officer of Incyte. “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.”
The sNDA submission is supported by data from the Phase 3 TRuE-AD3 trial, which demonstrated ruxolitinib cream’s efficacy and safety for children in the specified age group. The trial met its primary endpoint with significantly more patients treated with ruxolitinib achieving treatment success, measured by the Investigator’s Global Assessment (IGA) scale, compared to those treated with a vehicle cream. Additionally, a secondary endpoint showed at least 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8.
The safety profile in the TRuE-AD3 study was consistent with prior findings for Opzelura, with application site pain being the most common treatment-related adverse event. No serious infections or other major adverse events were recorded during the eight-week vehicle-controlled period.
Ruxolitinib cream, marketed as Opzelura, is already FDA-approved for certain uses in older age groups, including the treatment of nonsegmental vitiligo and mild to moderate atopic dermatitis in patients aged 12 and older. This extension underscores the importance of bringing effective treatments to younger patients while ensuring rigorous regulatory review.
If approved, Opzelura will provide younger pediatric patients with an innovative, non-steroidal option for managing a challenging and chronic condition. This milestone reflects the ongoing effort to expand safe and effective treatment options for children living with atopic dermatitis.
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