FDA accepts sNDA for ruxolitinib cream as a treatment for patients with vitiligo.

The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. The Prescription Drug User Fee Act (PDUFA) target action date is April 18, 2022.

“Vitiligo is a chronic autoimmune disease that can have a profound impact on people’s lives,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “Currently, there are no FDA-approved drug therapies for repigmentation in people with vitiligo. The FDA’s acceptance of our sNDA for ruxolitinib cream brings us one step closer to offering patients with vitiligo an additional treatment option.”

The sNDA is supported by data from the Phase III TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream in more than 600 people with non-segmental vitiligo, age 12 and older. Results from the Phase III program were recently presented at the 30th European Academy of Dermatology and Venereology (EADV) congress during a late-breaking research session. The data showed that at Week 24, 29.9% of patients applying ruxolitinib cream achieved greater than 75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint.