Update on FDA Review of Ruxolitinib Cream (Opzelura(R)) for Children Ages 2-11 with Atopic Dermatitis

Published: 2025-06-23 10:06:08 ET INCY

Published on 06/23/2025 at 10:06

WILMINGTON, Del. - Incyte (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura (R)), a topical Janus kinase (JAK) inhibitor, for the treatment of children 2-11 years old with mild to moderate atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to September 19, 2025.

The FDA extended the PDUFA action date to allow time to review additional chemistry, manufacturing and controls (CMC) data on the 0.75% strength submitted by Incyte in response to a recent FDA information request.

'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, 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 for ruxolitinib cream in pediatric AD 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