Incyte announced that data from a late-stage trial the pivotal Phase 3 found ruxolitinib cream was able to lead to add pigment for those suffering from the skin disease vitiligo.
The results were published in The New England Journal of Medicine.
The cream’s formulation is related to Incyte’s blockbuster Jakafi blood cancer drug. Incyte is based near Wilmington.
“Incyte is committed to developing innovative medicines for people with immune-mediated dermatologic conditions, and the publication of the TRuE-V results in NEJM is the culmination of years of work to advance science in vitiligo where there were no approved pharmacologic treatments for repigmentation,” said Jim Lee, group vice president, inflammation & autoimmunity at Incyte. “These pivotal results demonstrate significant improvements in facial and total body repigmentation with ruxolitinib cream, and we are proud that these data served as the foundation for the recent approval of ruxolitinib cream as the first and only U.S. Food and Drug Administration (FDA)-approved treatment for repigmentation in nonsegmental vitiligo.”
Key findings from the studies include:
- Results at Week 24, which were consistent across both studies, showed that approximately 30% of patients treated with ruxolitinib cream achieved 75% improvement At week 52, approximately 50% of patients who received ruxolitinib cream from Day 1 progressed
- Additionally, at Week 24, more than 15% of patients treated with ruxolitinib cream achieved a90% improvement.
Vitiligo is a chronic autoimmune disease characterized by the loss of pigment-producing cells known as melanocytes.
In the United States, more than 1.5 million people are diagnosed with vitiligo.. The overall prevalence of the condition is estimated to be approximately 2-3 million. Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 30..
In July 2022, Opzelura (ruxolitinib) cream was approved by the FDA for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
In 2021, Opzelura was approved by the FDA for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
