Incyte Plays Down Ruxolitinib Cream Label Worries Following Atopic Dermatitis Approval
Opzelura Is First Topical JAK Inhibitor Approved In US
Incyte welcomed FDA approval of its ruxolitinib cream, a selective JAK1/JAK2 inhibitor, as a treatment for atopic dermatitis, but criticized the boxed warnings label assigned to it.
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Incyte’s topical JAK inhibitor carries a class-wide severe safety warning and cautions against chronic use, but 52-week results could ease the way for the potential vitiligo indication.
Certain launch challenges aside, the early commercial metrics and physician feedback look encouraging for Incyte's recently-approved topical JAK Opzelura for eczema.
Major R&D efforts in immuno-dermatology produced multiple novel candidates in atopic dermatitis and psoriasis, while alopecia areata and vitiligo might see first therapies and JAK safety and COVID-19 logjams resolve.