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Ruxolitinib Receives MMA Validation from EMA for Vitiligo


Incyte announced that ruxolitinib cream has received validation for its European marketing authorization application from the European Medicines Agency.

Ruxolitinib (Opzelura; Incyte) cream, a topical Janise Kinase (JAK) inhibitor, has received European Marketing Authorization Application (MAA) validation from the European Medicines Agency (EMA) for the potential treatment for patients 12 years and older with non-segmental vitiligo with facial involvement.1 

“The EMA’s validation of the MAA for ruxolitinib cream marks an important milestone for people with vitiligo, for whom there is often a significant impact on everyday life and who currently have limited treatment options,” said Jonathan Dickinson, general manager Europe, executive vice president at Incyte, Switzerland. “We are committed to listening to the patient community to understand how we can help fulfill unmet needs and support healthcare providers to better manage this challenging disease. We look forward to working with the regulatory authorities, with the aim to bring this new potential therapy to eligible patients as soon as possible.”

The results from the 2 phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), supported the decision. 

The clinical trial program evaluated the safety and efficacy of ruxolitinib cream in more than 600 patients aged 12 and older with vitiligo. Results from the trials demonstrated significant improvements in facial and total body repigmentation at 24 weeks of treatment with ruxolitinib cream in patients with vitiligo. In the studies, patients using ruxolitinib cream did not report clinically significant application site reactions, and the overall safety profile was consistent with previous study data, according to the release.

Data like this and more will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) annual scientific meeting this weekend, November 4 to 8, in New Orleans, Louisiana. 


1. Incyte announces the validation of the European marketing authorization application for ruxolitinib cream in vitiligo. Published October 28, 2021. Accessed November 4, 2021. https://investor.incyte.com/press-releases/press-releases/2021/Incyte-Announces-the-Validation-of-the-European-Marketing-Authorization-Application-for-Ruxolitinib-Cream-in-Vitiligo/default.aspx

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