FDA Extends INCY's Application for Opzelura Label Expansion

Key Takeaways Incyte's sNDA for ruxolitinib cream in kids with AD now has a new FDA action date of Sept. 19, 2025. The delay allows the FDA to review the added CMC data on the 0.75% formulation of the cream. Opzelura met key efficacy endpoints in the phase III TRuE-AD3 study supporting the sNDA filing. Incyte (INCY) announced that the FDA has extended the review period for the supplemental new drug application (sNDA) for ruxolitinib cream.The sNDA is seeking approval of the cream for the treatment of chil ...