Press release
MHRA Grants Marketing Authorisation for Opzelura® (ruxolitinib) Cream for the Treatment of Non-Segmental Vitiligo with Facial Involvement in Adults and Adolescents
Opzelura® is the first approved treatment in the United Kingdom (UK) to address repigmentation in non-segmental vitiligo Phase 3 data supporting the approval
About this update from Incyte Corporation
[{"type":"text","content":"\n\nOpzelura® is the first approved treatment in the United Kingdom (UK) to address repigmentation in non-segmental vitiligo\n\n\n\nPhase 3 data supporting the approval show treatment with ruxolitinib cream resulted in improved facial and total body repigmentation, sustained and continued improvements with longer duration of treatment\n\n\n\nVitiligo affects around 1 in 100 people in the UK\n\n\n\n LEATHERHEAD, England--(BUSINESS WIRE)--\nIncyte Biosciences UK today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Opzelura® (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 United Kingdom (UK) to offer eligible patients with non-segmental vitiligo support for repigmentation. The MHRA decision follows the European Commission approval1 earlier in April.\n\n\n“Today’s MHRA approval is welcome news for dermatologists and people with vitiligo seeking treatment who until now have had limited options. The data supporting this approval demonstrate the potential for ruxolitinib cream to make a difference in the lives of people living with this condition,” said Dr. Viktoria Eleftheriadou, Consultant Dermatologist & Lead for Vitiligo Clinic and Research, Walsall Healthcare NHS Trust and The Royal Wolverhampton NHS Trust.\n\n\nVitiligo 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 melanocytes2. Around 1 in 100 people in the UK develop vitiligo3,4 with approximately 8 in 10 patients suffering from non-segmental vitiligo, where both sides of the body are affected by symmetrical white patches5. Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 304, and have a significant impact on people living with the condition6.\n\n\n“While more and more people are proud of their vitiligo, there are still so many people who don’t feel comfortable in their skin,” said Emma Rush, Founder and Chief Executive Officer, Vitiligo Support UK. “This new treatment option provides a choice for those who wish to treat their condition.”\n\n\nThe MHRA decision is based on data from two ...