Benzinga | Oct 28, 2021 07:48AM EDT

Incyte Reports Validation Of European Marketing Authorization Application For Ruxolitinib Cream In Vitiligo

- The MAA seeks approval of ruxolitinib cream for the treatment of adolescent and adult patients with non-segmental vitiligo with facial involvement

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (NASDAQ:INCY) today announced 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 EMA's validation of the MAA for ruxolitinib cream marks an important milestone for people with vitiligo, for whom there is often a significant impact on everyday life and who currently have limited treatment options," said Jonathan Dickinson, General Manager Europe, Executive Vice President at Incyte. "We are committed to listening to the patient community to understand how we can help fulfill unmet needs and support healthcare providers to better manage this challenging disease. We look forward to working with the regulatory authorities, with the aim to bring this new potential therapy to eligible patients as soon as possible."

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. Results from the Phase 3 program, recently presented at the 30th European Academy of Dermatology and Venereology (EADV) congress during a late-breaking research session, showed significant improvements in facial and total body repigmentation at 24 weeks of treatment with ruxolitinib cream in people with vitiligo. In the TRuE-V studies, patients using ruxolitinib cream did not report clinically significant application site reactions, and the overall safety profile was consistent with previous study data.

Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes. Over-activity of the JAK signaling pathway has been shown to drive inflammation involved in the pathogenesis and progression of vitiligo. It affects approximately 0.5% to 2.0% of the population globally1 and there are no U.S. Food and Drug Administration (FDA) or EMA-approved drug therapies for regimentation in vitiligo. The disease can occur at any age, although many patients with vitiligo will experience initial symptoms before the age of 20.2