Policy & Regulation
US FDA Accepts for Priority Review NDA for Ruxolitinib Cream for Atopic Dermatitis
19 February 2021 - - The US Food and Drug Administration has accepted for Priority Review the New Drug Application for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis, a type of eczema, US-based Incyte (NASDAQ: INCY) said.

The NDA is supported by data from the Phase 3 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 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.

Atopic dermatitis is a chronic skin disease, affecting more than 21 m people in the United States and is characterized by inflammation and intense itch.

Signs and symptoms of AD include irritated and itchy skin that can cause red lesions that may ooze and crust.

Patients with AD are also more susceptible to bacterial, viral and fungal infections.

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.

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 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; 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 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.

TRuE-AD results presented at the 29th European Academy of Dermatology and Venereology Congress in October 2020 examined sleep quality, sleep depth and restoration associated with sleep, key quality of life measures for people with AD.

Ruxolitinib cream is a proprietary formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application.

Ruxolitinib cream 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 science-first approach and expertise in immunology has formed the foundation of the company.

In Dermatology, the company's research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.

Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo and hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company.