The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for the topical formulation of the JAK inhibitor ruxolitinib as a treatment of atopic dermatitis (AD) in children aged 2-11 years, according to a press release from the manufacturer.

The new PDUFA date is September 19, 2025, according to the company, Incyte.

The review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura) was extended to provide time for the FDA to review additional data on chemistry, manufacturing, and controls related to the 0.75% formulation, according to the press release.

Topical ruxolitinib cream (1.5%) is approved by the FDA for short-term and noncontinuous chronic treatment of mild-to-moderate AD in patients aged 12 years or older who are not immunocompromised for whom topical prescription therapies are contraindicated or insufficient for disease control. Topical ruxolitinib also is approved for nonsegmental vitiligo in patients aged 12 years or older in the US.

The sNDA for the AD indication in younger children is based on data from a phase 3 study known as TRuE-AD3, in which children aged 2-12 years with mild-to-moderate AD were randomly assigned to 0.75% or 1.5% ruxolitinib cream or a vehicle. In the study, significantly more children treated with ruxolitinib compared with placebo met the primary endpoint of treatment success based on the Investigator’s Global Assessment-Treatment Success measure.

Treatment was well-tolerated overall, consistent with previous studies of topical ruxolitinib, with no new safety signals noted. The most common treatment-related adverse event in ruxolitinib-treated patients was application site pain, but no treatment-related events prompted discontinuation, according to the press release.

The TRuE-AD3 study was funded by Incyte.