Incyte reports promising results of a drug that treats skin diseases

Incyte announced that data from a late-stage, pivotal Phase 3 trial found that ruxolitinib cream was able to add pigment for people with vitiligo, a skin condition.

The results were published in The New England Journal of Medicine.

The formulation of the cream is related to Incyte’s blockbuster blood cancer drug Jakafi. Incyte is based near Wilmington.

“Incyte is committed to developing innovative medicines for people with immune-mediated skin diseases, and the publication of TRuE-V results in NEJM is the culmination of years of work to advance the science of vitiligo when there were no approved pharmacological treatments for repigmentation,” said Jim Lee, group vice president, inflammation and autoimmunity at Incyte. “These breakthrough results demonstrate significant improvements in facial and full-body repigmentation with ruxolitinib cream, and we are proud that these data served as the basis for the recent approval of ruxolitinib cream as the first and only US Food and Drug Administration (FDA) approval treatment of repigmentation in non-segmental 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 a 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 a 90% improvement.

Vitiligo is a chronic autoimmune disease characterized by the loss of pigment-producing cells called melanocytes.

In the United States, more than 1.5 million people are diagnosed with vitiligo.. The global prevalence of the disease is estimated at around 2 to 3 million people. Vitiligo can occur at any age, although many patients with vitiligo manifest before the age of 30...

In July 2022, Opzelura Cream (ruxolitinib) 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 chronic, short-term, noncontinuous topical treatment of mild to moderate atopic dermatitis in nonimmunocompromised patients 12 years of age and older whose disease is not adequately controlled with prescription topical treatments, or when these therapies are not recommended.