MHRA Grants Marketing Authorization for Incyte's Opzelura Cream for Non-Segmental Vitiligo with Facial Involvement in Adults and Adolescents

July 5, 2023

The JAK inhibitor is approved for the topical treatment of non-segmental vitiligo and mild to moderate atopic dermatitis in the US.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing clearance for Incyte’s Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. 

“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,” says Dr. Viktoria Eleftheriadou, Consultant Dermatologist & Lead for Vitiligo Clinic and Research, Walsall Healthcare NHS Trust and The Royal Wolverhampton NHS Trust, in a news release.

The MHRA regulates medicines, medical devices and blood components for transfusion in the UK. This decision follows the European Commission approval earlier in April. It is based on data from two pivotal Phase 3 clinical trials (TRuE-V1 [NCT04052425] and TRuE-V2 [NCT04057573]), evaluating the efficacy and safety of ruxolitinib cream versus vehicle (non-medicated cream) in more than 600 people with non-segmental vitiligo, age 12 and older. 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 (F-VASI-T-VASI) endpoints at Week 24 compared to vehicle 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 ruxolitinib cream achieved ≥75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint, compared to 7.4% and 11.4% of patients treated with vehicle in TRuE-V1 and TRuE-V2, respectively. At Week 52, approximately one in two of ruxolitinib cream-treated patients achieved F-VASI75. Additionally, at Week 52, approximately one in three of ruxolitinib cream-treated patients achieved ≥90% improvement from baseline in F-VASI (F-VASI90).

There were no serious treatment-related adverse events related to ruxolitinib cream and the most common adverse reaction was application site acne7.

“While more and more people are proud of their vitiligo, there are still so many people who don’t feel comfortable in their skin,” says 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.”

John Dunster, Chairperson, The Vitiligo Society, agrees: ”A new treatment specifically approved for vitiligo in the UK is a significant milestone and furthers our goal at The Vitiligo Society to support, inspire and educate people about vitiligo.”  said John Dunster, Chairperson, The Vitiligo Society.

In the United States, ruxolitinib cream is approved for the topical treatment of non-segmental vitiligo in patients 12 years of age and older. Ruxolitinib cream is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. 

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