Opzelura (ruxolitinib) cream is the first and only FDA-approved treatment for adult and pediatric patients 12 years of age or older with vitiligo.
Incyte announced the FDA has approved ruxolitinib cream 1.5% as a topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age or older.1 The groundbreaking approval is the only FDA-approved treatment for repigmentation and the only topical formulation of a JAK inhibitor approved in the US. Vitiligo is an autoimmune disease that causes sections of the skin to lose their pigment (color), causing white patches of skin to appear. Melanocytes are attacked and destroyed by the body’s immune system and can occur anywhere in the body.2
Ruxolitinib provides relief to patients with nonsegmental vitiligo that had high unmet medical needs and no previously approved therapy options. For the best results, patients should apply ruxolitinib cream twice daily to the affected areas of skin, up to 10% of body surface area. It may take more than 24 weeks for patients using ruxolitinib cream to see satisfactory results.
The approval was based on data from the phase 3 TRuE-V clinical trial program (TRuE-V1 and TRuE-V2), which evaluated the safety and efficacy of ruxolitinib in over 600 people with nonsegmental vitiligo, aged 12 years and older. Results at week 24 showed that approximately 30% of patients using ruxolitinib achieved ≥75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75). By Week 52, approximately 50% of patients treated with ruxolitinib achieved F-VASI75.1
“Vitiligo is an immune-mediated disease that can be unpredictable, making it particularly difficult to treat,” said David Rosmarin, MD, vice chair of research and education, department of dermatology at Tufts Medical Center in Boston, Massachusetts. “There have been no FDA-approved therapies available to date and the approval of Opzelura therefore marks a significant milestone. I welcome a medical treatment that helps my patients with nonsegmental vitiligo who are interested in potentially reversing the depigmentation caused by their disease.”
Common adverse effects of ruxolitinib in people treated for nonsegmental vitiligo include acne at the application site, itching, common cold, headache, urinary tract infection, redness, and fever.