Press release
Incyte Announces First Presentation of Phase 3 Data from the TRuE-AD Program of Ruxolitinib Cream at the Revolutionizing Atopic Dermatitis Virtual Symposium
- Ruxolitinib cream resulted in a rapid and robust clinical response, with significantly more patients achieving Investigator’s Global Assessment (IGA)
About this update from Incyte Corporation
[{"type":"text","content":"\n- Ruxolitinib cream resulted in a rapid and robust clinical response, with significantly more patients achieving Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS; primary endpoint), defined as an IGA score of 0 (clear) or 1 (almost clear), and EASI75 (key secondary endpoint), defined as the proportion of patients who achieved a ≥ 75% improvement in the Eczema Area and Severity Index Score\n- Treatment with ruxolitinib cream also resulted in a rapid, substantial and sustained reduction in itch, a key quality of life measure for patients with atopic dermatitis\n- Data support the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration before the end of 2020\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq: INCY) today announced the first presentation of Phase 3 data for ruxolitinib cream in atopic dermatitis at the Revolutionizing Atopic Dermatitis Virtual Symposium. The Phase 3 TRuE-AD program, which includes the TRuE-AD1 and TRuE-AD2 studies, is evaluating ruxolitinib cream 0.75% and 1.5% twice daily (BID) for the treatment of patients with mild-to-moderate atopic dermatitis.\n\n\n“Data that will be presented today during the Revolutionizing Atopic Dermatitis Virtual Symposium show that ruxolitinib cream significantly reduced both the skin inflammation and itch associated with atopic dermatitis. The reduction in itch can potentially improve key disease-related and quality of life outcomes for patients living with atopic dermatitis,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte. “We are pleased to share these important data with the dermatology community, as they support the potential of ruxolitinib cream to become an important antipruritic and anti-inflammatory treatment option for patients with atopic dermatitis, and we look forward to submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration later this year.”\n\n\nThe primary endpoint for the TRuE-AD1 and TRuE-AD2 studies was the proportion of patients achieving Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline, at Week 8. Key secondary endpoints included the proportion of patients who achieved a ≥ 75% improvement in Eczema Area an...