The PDUFA target action date is June 21, 2021.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) of Incyte’s ruxolitinib cream for atopic dermatitis (AD) for priority review.

The Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2021.

Ruxolitinib cream is a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for AD. It is currently in Phase 3 development for the treatment of atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.

“Incyte’s deep understanding of the pathways involved in immune-mediated skin conditions led us to investigate the potential for ruxolitinib cream to address key factors associated with atopic dermatitis, that is, inflammation of the skin and itch,” says Jim Lee, MD, PhD, Group Vice President, Inflammation & Autoimmunity, Incyte, in a news release. “We are grateful to the people living with atopic dermatitis whose participation in our clinical trials helped generate the evidence to support this regulatory submission, and we look forward to working with the FDA as we seek to bring forward a new topical treatment for people living with this chronic skin disease.”

The NDA is supported by data from the Phase 3 TRuE-AD clinical trial program, which included more than 1,200 people, aged 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.

More About TRuE-AD 

The TRuE-AD clinical trial program consists of two randomized, double-blind, vehicle-controlled Phase 3 studies, TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651), evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD). Both studies enrolled more than 600 patients (age ≥12 years) diagnosed with AD for at least two years and who were candidates for topical therapy.Patients with an Investigator’s Global Assessment (IGA) score of 2 to 3, and with AD on 3% to 20% of their Body Surface Area (excluding scalp) were randomized 2:2:1 into one of three arms for eight weeks: ruxolitinib cream 0.75% applied twice daily (BID); ruxolitinib cream 1.5% applied BID; and vehicle. Participants who successfully completed an assessment at Week 8 were offered participation in the 44-week long-term safety treatment extension period with ruxolitinib cream 0.75% or 1.5% applied BID.

The primary endpoint of the TRuE-AD studies was the proportion of participants achieving an Investigator’s Global Assessment Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at Week 8. Key secondary endpoints include: the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) score, the proportion of participants with at least a 4-point improvement in the itch Numerical Rating Scale, and the proportion of participants with at least a 6-point improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form – Sleep Disturbance (8b) 24-hour recall score. Additional secondary endpoints include mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score. The studies have also been tracking the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.