Incyte announces FDA extends review period for Opzelura sNDA

The company states: “Incyte (INCY) announced that the 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 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 data on the 0.75% strength submitted by Incyte in response to a recent FDA information request.” Steven Stein, M.D., Chief Medical Officer, Incyte stated: “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.”