Incyte receives FDA OK for new indication for Opzelura
Incyte has received the Food and Drug Administration’s green light for Opzelura (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients aged 12 years old and older.
Opzelura is the first and only FDA-approved treatment for repigmentation in patients with vitiligo, and the only topical formulation of a Janus kinase inhibitor approved in the United States, the company said.
“With the approval of Opzelura in nonsegmental vitiligo, Incyte has once again delivered a treatment to patients with high unmet medical need who previously had no approved therapies,” said Hervé Hoppenot, CEO of Incyte.“We are proud of Incyte’s scientists and development teams that have made this milestone possible, and we’re pleased that eligible vitiligo patients now have a choice to address repigmentation.”
[Read more: Incyte wins FDA nod for Opzelura]
The company noted that vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes. Overactivity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo.
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 to 3 million, with the majority of patients (approximately 85%) suffering from nonsegmental vitiligo. Vitiligo can occur at any age, although many patients with vitiligo will experience initial symptoms before the age of 30.
“Vitiligo is an immune-mediated disease that can be unpredictable, making it particularly difficult to treat,” said David Rosmarin, vice chair of research and education, department of dermatology at Tufts Medical Center.
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“There have been no FDA-approved therapies available to date, and the approval of Opzelura therefore marks a significant milestone,” he said. “I welcome a medical treatment that helps my patients with nonsegmental vitiligo who are interested in potentially reversing the depigmentation caused by their disease.”
In September 2021, Opzelura was approved by the FDA for the topical short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients aged 12 years old and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.