FDA Approves Ruxolitinib: New Horizons in Vitiligo Care

On Monday, the US Food and Drug Administration (FDA) approved ruxolitinib cream 1.5% for the treatment of nonsegmental vitiligo in adults and pediatric patients 12 years and older, making it both the first FDA-approved therapy for repigmentation and the only topical formulation of a JAK inhibitor approved in the United States.

The groundbreaking approval was supported by phase 3 data from the TRue-V clinical trial program, which found that roughly 3 in 10 patients who were treated with ruxolitinib cream achieved ≥90% improvement on facial vitiligo regimentation after 52 weeks of treatment.

David Rosmarin, MD, Vice Chair for Research and Education at Tufts Medical Center and leading investigator of the True-V program joined us on DocTalk to share his enthusiasm for the approval and speak on how ruxolitinib cream could offer hope to patients who can’t access or properly respond to standard treatment.

“One of the challenges with treating vitiligo is that our big treatment is phototherapy, and that's really inconvenient and inaccessible for many; to have to come into an office for light treatments 2 to 3 times a week is really inconvenient, and sometimes prohibitive,” Rosmarin said “It can also be very costly if there are co-pays each time a patient needs phototherapy. So, having an option where patients can use,at home, a cream twice a day, and the convenience of that, is really important. The best ability is availability. If a patient can't access a treatment, it's no good.”