Incyte’s Opzelura (ruxolitinib) cream has been approved by the European Commission (EC) to treat adults and adolescent patients aged 12 years and older with non-segmental vitiligo with facial involvement.
Vitiligo is a chronic autoimmune disorder that causes patches of skin to lose pigment or colour. This happens when pigment-producing cells known as melanocytes are attacked and destroyed.
The EC’s decision, which follows a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use earlier this year, makes the JAK inhibitor the first and only approved treatment in the EU to target repigmentation in this patient population.
The company’s application was supported by data from two phase 3 clinical trials – TRuE-V1 and TRuE-V2 – evaluating the safety and efficacy of Opzelura versus non-medicated cream (vehicle) in more than 600 non-segmental vitiligo patients.
Results showed that treatment with Opzelura resulted in significant improvements in facial and total body repigmentation versus vehicle, as shown by the number of patients reaching the facial and total body Vitiligo Area Scoring Index (F-VASI) endpoints at week 24 and in an open-label extension at week 52.
Results at week 24, which were consistent across both studies, showed that 29.8% and 30.9% of patients treated with Opzelura achieved at least a 75% improvement from baseline in the F-VASI, compared to 7.4% and 11.4% of patients treated with vehicle in TRuE-V1 and TRuE-V2, respectively.
Additionally, at week 24, more than 15% of patients treated with Opzelura achieved at least a 90% improvement from baseline in F-VASI, compared to approximately 2% of patients treated with vehicle.
Hervé Hoppenot, chief executive officer at Incyte, said: “The approval of Opzelura by the EU 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.”
Hoppenot added that the company will now “work across individual countries in Europe” to bring the treatment to eligible patients.
Professor Dr Markus Böhm, department of dermatology at the University of Münster in Germany, said: “The approval of Opzelura is welcome news for dermatologists and eligible patients in Europe who often face challenges managing vitiligo.
“TRuE-V is the first large-scale clinical trials programme in vitiligo and its results clearly demonstrate the clinically meaningful improvements in facial and total body repigmentation seen with Opzelura and its potential to further optimise patient care and outcomes.”