Incyte has secured marketing authorization for Opzelura (ruxolitinib) cream 15mg/g from the European Commission (EC) for non-segmental vitiligo with facial involvement in adults and adolescents, aged 12 years and above.

Opzelura is a cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib. It has been approved in the European Union (EU) to offer support for repigmentation in qualified patients who have non-segmental vitiligo. The approval is valid in all 27 European Union member states along with Iceland, Liechtenstein, and Norway.

According to Incyte, Opzelura EC approval comes after the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) earlier this year.

It has been driven by the findings of a couple of phase 3 TRuE-V clinical trials that assessed the efficacy and safety of Opzelura compared to vehicle (non-medicated cream) in over 600 patients having non-segmental vitiligo, age 12 and older.

Data from the TRuE-V clinical program demonstrated that treatment with Opzelura led to substantial improvements in facial and total body repigmentation compared to vehicle as proven by the number of patients achieving the facial and total body Vitiligo Area Scoring Index (F-VASI-T-VASI) endpoints at Week 24 in comparison to vehicle as well as in an open-label extension at Week 52.

Commenting on Opzelura EC approval, Hervé Hoppenot — Incyte CEO said: “The approval of Opzelura by the European Commission represents a significant advancement for people living with non-segmental vitiligo with facial involvement who, until now, had no approved medical treatment to address repigmentation.

“This approval wouldn’t have been possible without the support of the vitiligo patient and medical community, and the efforts of our research and development teams. We will now work across individual countries in Europe to bring this much awaited therapy to eligible patients seeking to treat their vitiligo.”

Opzelura has approval in the US for the topical treatment of non-segmental vitiligo in people, 12 years and older. It is also approved in the US for the topical short-term and non-continuous chronic treatment of atopic dermatitis (AD) in non-immunocompromised patients 12 years and older, whose condition is mild to moderate and whose disease is not controlled adequately with topical prescription therapies, or when those therapies are not suitable.

Incyte holds global rights to the commercialization and development of Opzelura. The company signed an alliance agreement in April 2022 with Maruho to develop, manufacture, and exclusively commercialize ruxolitinib cream for inflammatory and autoimmune dermatology conditions in Japan.

  European Commission, European Medicines Agency, European Union, Herve Hoppenot, Incyte, Opzelura, ruxolitinib, vitiligo