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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Approved for psoriasis, Vtama met the primary and secondary endpoints in first of two Phase III atopic dermatitis studies. The Roivant affiliate will position the drug as a two-in-one solution for both.
With Opzelura approved for vitiligo in July, Incyte acquires Villaris and its preclinical IL-15-targeted antibody to potentially add to its vitiligo portfolio.
Opzelura, already approved for atopic dermatitis, gives Incyte a second indication for its topical JAK inhibitor. It is the first treatment approved for vitiligo.