Ruxolitinib Granted Marketing Authorization in United Kingdom

Incyte Biosciences UK has announced¹ that ruxolitinib (Opzelura) has been granted marketing authorization in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency (MHRA).

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The authorization comes just 2 months after the drug’s approval by the European Commission for the treatment of non-segmental vitiligo. Similarly to the US, ruxolitinib cream is the only approved treatment option for patients with non-segmental vitiligo.

The specific authorization encompasses a 15 mg/g dose of ruxolitinib and includes adult and adolescent patients ages 12 years and older.

The approval and authorization of ruxolitinib stems from the results of phase 3 clinical trials, TRuE-V1 and TRuE-V2 (NCT04052425 and NCT04057573), wherein ruxolitinib cream demonstrated significant efficacy and repigmentation in patients with non-segmental vitiligo.

Among the lack of serious adverse events from the trials, researchers also found that 29.8% (TRuE-V1) and 30.9% (TRuE-V2) of patients achieved an equal to or greater than 75% Vitiligo Area Severity Index score at week 24 from baseline. This was compared to 7.4% and 11.4% of patients achieving the same metric while receiving a placebo treatment.

Leaders of Vitiligo Support UK and The Vitiligo Society are among those championing the authorization.

“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 in a press release.¹ Rush is the founder and chief executive officer of Vitiligo Support UK. “This new treatment option provides a choice for those who wish to treat their condition.”

John Dunster, chairperson of The Vitiligo Society, described the drug’s approval and authorization as, “a significant milestone.”

“Today’s MHRA approval is welcome news for dermatologists and people with vitiligo seeking treatment who until now have had limited options,” said Viktoria Eleftheriadou, MD, PhD, in the press release.¹ Eleftheriadou is a consultant dermatologist and lead for Vitiligo Clinic and Research at Walsall Healthcare NHS Trust and The Royal Wolverhampton NHS Trust. "The data supporting this approval demonstrate the potential for ruxolitinib cream to make a difference in the lives of people living with this condition.”

Reference

1. MHRA Grants Marketing authorisation for Opzelura® (ruxolitinib) cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents. Business Wire. July 5, 2023. Accessed July 5, 2023. https://www.businesswire.com/news/home/20230705273477/en/MHRA-Grants-Marketing-Authorisation-for-Opzelura%C2%AE-ruxolitinib-Cream-for-the-Treatment-of-Non-Segmental-Vitiligo-with-Facial-Involvement-in-Adults-and-Adolescents.