FDA accepts NDA and priority review for Jakavi in atopic dermatitis.- Incyte

Incyte announced that the FDA has accepted for Priority Review the New Drug Application (NDA) for Jakavi (ruxolitinib cream), a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis (AD), a type of eczema. The NDA is supported by data from the Phase III TRuE-AD clinical trial program, which included more than 1,200 people, age 12 years and older. Primary efficacy and safety results from both TRuE-AD trials were presented at the Revolutionizing Atopic Dermatitis Virtual Symposium in April 2020. Additional safety and efficacy data from the 44-week, open-label, long-term extension of both TRuE-AD1 and TRuE-AD2 were included in the NDA. Incyte submitted a priority review voucher (PRV) along with the NDA application for ruxolitinib cream. The use of the PRV shortens the review period by four months. The Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2021.