Incyte UK announces that MHRA granted authorization for Opzelura cream

Incyte Biosciences UK announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, has granted marketing authorisation for Opzelura, or ruxolitinib, cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Opzelura is the first and only approved treatment in the UK to offer eligible patients with non-segmental vitiligo support for repigmentation. The MHRA decision follows the European Commission approval earlier in April. Vitiligo is a chronic autoimmune disease in which areas of skin depigment or lose their colour due the progressive destruction of pigment-producing cells known as melanocytes. The MHRA decision is based on data from two pivotal Phase 3 clinical trials, evaluating the efficacy and safety of ruxolitinib cream versus vehicle in more than 600 people with non-segmental vitiligo, age 12 and older7. Results from the TRuE-V program showed that treatment with ruxolitinib cream 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 endpoints at Week 24 compared to vehicle and in an open-label extension at Week 527. Results at Week 24, which were consistent across both studies, showed that 29.8% and 30.9% of patients treated with ruxolitinib cream achieved greater than or equal to75% improvement from baseline in the facial Vitiligo Area Scoring Index, the primary endpoint, compared to 7.4% and 11.4% of patients treated with vehicle in TRuE-V1 and TRuE-V2, respectively7.