Delaware-based Incyte reported that the U.S. Food and Drug Administration approved Opzelura (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Opzelura is the first FDA-approved treatment for repigmentation in patients with vitiligo, and the only topical formulation of a Janus kinase (JAK) inhibitor approved in the United States. Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin.
Incyte has worked to expand the uses of JAK drugs, following the success of the blockbuster blood cancer drug Jakafi.
In early trading, Incyte shares were up by 1.5% to about $80 a share.
Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells. Over-activity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo. In the United States, more than one and a half million people are diagnosed with vitiligo. The overall prevalence of the condition is estimated to be approximately two million to three million.
“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, Incyte CEO. “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.”
In patients with non-segmental vitiligo, Opzelura is approved for continuous topical use twice daily to affected areas of up to 10% body surface area. Satisfactory patient response may require treatment with Opzelura for more than 24 weeks, a release stated.
Results at Week 24, which were consistent across both studies, showed that approximately 30% of patients treated with Opzelura achieved a 75% or more improvement. Also at 24 weeks, more than 15% of patients treated with Opzelura saw a greater than 90% improvement. Comparisons were made with a topical cream.
The labeling for Opzelura includes a Boxed Warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. Concerns over side effects led the FDA to delay final approval.
“Vitiligo is an immune-mediated disease that can be unpredictable, making it particularly difficult to treat,” said David Rosmarin, M.D., vice chair of research and education, Department of Dermatology at Tufts Medical Center. “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.”
In September 2021, Opzelura was approved by the FDA for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) 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.
Sales of Opzelura are now running at $90 million a quarter, with Incyte adding another manufacturing site as Incyte dealt with an issue over the texture of the cream.
Eligible patients in the United States who are prescribed Opzelura have access to IncyteCARES, a program offering patient support, including financial assistance and ongoing education and resources to eligible patients.
Cost of the drug is listed at $2,062.85 for 60 grams. As noted above, programs and discounts are available.
Incyte is based near Wilmington.