The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream (Incyte) for the treatment of atopic dermatitis.

The NDA is supported by data from 2 randomized, double-blind, vehicle-controlled trials (TRuE-AD1; ClinicalTrials.gov: NCT03745638) and TRuE-AD2; ClinicalTrials.gov: NCT03745651) that evaluated the efficacy and safety of a topical cream formulation of ruxolitinib, a selective JAK1/JAK2 inhibitor, in 1250 patients 12 years of age and older with atopic dermatitis. Patients were randomly assigned 2:2:1 to receive ruxolitinib cream (0.75% or 1.5%) twice daily or vehicle cream (non-medicated) for 8 weeks.

The primary end point for both trials was the proportion of patients achieving an Investigator’s Global Assessment Treatment Success (IGA-TS), defined as a score of 0 (clear) or 1 (almost clear). Key secondary end points included the proportion of patients with greater than or equal to 75% improvement from baseline in the Eczema Area and Severity Index (EASI75) score and at least a 4-point improvement in Itch Numerical Rating Scale (NRS4) score at week 8.

Findings from TRuE-AD1 showed that 50% of patients treated with ruxolitinib cream 0.75% and 53.8% of patients treated with ruxolitinib cream 1.5% achieved IGA-TS compared with 15.1% treated with vehicle control (P <.0001 for both). Additionally, 56% of patients treated with ruxolitinib cream 0.75% and 62.1% of patients treated with ruxolitinib cream 1.5% achieved EASI75 compared with 24.6% treated with vehicle control (P <.0001 for both).


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In TRuE-AD2, the primary end point was achieved by 39% of patients treated with ruxolitinib cream 0.75% and 51.3% of patients treated with ruxolitinib cream 1.5% compared with 7.6% treated with vehicle control (P <.0001 for both). Moreover, 51.5% of patients treated with ruxolitinib cream 0.75% and 61.8% of patients treated with ruxolitinib cream 1.5% achieved EASI75 compared with 14.4% treated with vehicle control (P <.0001 for both).

Both studies demonstrated a clinically meaningful reduction in itch as measured by the NRS4 for ruxolitinib cream (0.75% and 1.5%) compared with vehicle control. Patients treated with ruxolitinib cream 1.5% also achieved a statistically significantly greater reduction in itch NRS within 12 hours of treatment compared with vehicle control (P <.05). 

The NDA submission also includes data from the 44-week, open-label, long term extension of both trials.

A Prescription Drug User Fee Act (PDUFA) target date of June 21, 2021 has been set for this application.

References

  1. Incyte announces acceptance and Priority Review of NDA for ruxolitinib cream for atopic dermatitis. [press release]. Wilmington, DE: Incyte; February 19, 2021. 
  2. Incyte announces first presentation of phase 3 data from the TRuE-AD program of ruxolitinib cream at the Revolutionizing Atopic Dermatitis Virtual Symposium. [press release]. Wilmington, DE: Incyte; April 5, 2020.