The US Food and Drug Administration (FDA) has approved Incyte’s Opzelura (ruxolitinib) cream 1.5% for the topical treatment of non-segmental vitiligo in adult and paediatric patients 12 years of age and older.
With this latest approval, Opzelura is the first and only FDA-approved treatment for repigmentation in patients with vitiligo. It is also the only topical formulation of a Janus kinase (JAK) inhibitor approved in the US.
Vitiligo is a chronic autoimmune disease presenting in a depigmentation of the skin that is caused by the loss of melanocytes, which are pigment-producing cells. More than 1.5 million people are diagnosed with vitiligo in the US, while the total prevalence of the condition is estimated to be around two to three million, with the majority of patients – approximately 85% – suffering from nonsegmental vitiligo.
An over-activity of the JAK signalling pathway is thought to further drive inflammation involved in the progression of vitiligo.
The FDA based its decision on results taken from the pivotal phase 3 TRuE-V clinical trial programme (TRuE-V1 and TRuE-V2), which assessed the safety and efficacy of Opzelura versus non-medicated cream in more than 600 people with nonsegmental vitiligo, specifically in those aged 12 years and older.
The results demonstrated that treatment with Opzelura resulted in significant improvements in Vitiligo Area Severity Index (VASI) scores, which represent improvements in facial and complete body repigmentation at week 24 – primary analysis – compared to non-medicated cream and in an open-label extension at week 52.
“With the approval of Opzelura in nonsegmental vitiligo, Incyte has delivered a treatment to patients with high unmet medical need who previously had no approved therapies,” said Hervé Hoppenot, chief executive officer at Incyte.
He added: “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.”
Opzelura has been approved for continuous topical use twice daily to affected areas of up to 10% body surface area for patients with non-segmental vitiligo.
Opzelura was approved by the FDA in September 2021 for the topical short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription treatments, or when those treatments are not suitable.