INCY - EMA validates Incyte's ruxolitinib MAA as potential treatment of non-segmental vitiligo

Incyte (NASDAQ:INCY) announces the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream, a topical JAK inhibitor, as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement. The validation of the MAA by the European Medicines Agency (EMA) confirms that the submission is ready to enter the formal review process. The MAA is supported by data from the Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream in more than 600 people (age >12 years) with vitiligo. Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes.

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EMA validates Incyte's ruxolitinib MAA as potential treatment of non-segmental vitiligo