Incyte announced positive two-year results from the pivotal Phase 3 TRuE-V clinical trial program evaluating Opzelura (ruxolitinib) cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo, a chronic autoimmune disease characterized by the loss of pigment of skin.
Incyte is based near Wilmington.
The 104-week long-term extension (LTE) data builds on studies previously published in The New England Journal of Medicine.
Opzelura sales in 2022 were $129 million. Opzelura is related to incyte’s blockbuster blood cancer drug Jakafi and is also used to treat other kind conditions. The market for such drugs is competitive, with Incyte launching a television commercial featuring the treatment for vitiligo with Opzelura. (See below)
“I am extremely encouraged by these data, which show continued improvements in facial and total body repigmentation over two years of treatment with Opzelura,” said David Rosmarin, M.D., Chair, Department of Dermatology at Indiana University School of Medicine. “Vitiligo is a chronic condition and these results demonstrate the long-term potential of this medical treatment for people with vitiligo who are interested in repigmentation.”
Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. 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. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.
On February 24, Incyte announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of ruxolitinib cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. In April 2022, Incyte entered into a strategic alliance agreement with Maruho Co., Ltd. for the development, manufacturing and exclusive commercialization of ruxolitinib cream for treatment of autoimmune and inflammatory dermatology indications in Japan.
In the United States, more than 1.5 million people are diagnosed with vitiligo. The overall prevalence of the condition is estimated to be about 2-3 million.