Ruxolitinib approved for vitiligo

The European Commission (EC) has given authorization for ruxolitinib (Opzelura) cream 15 mg/g to be marketed for treating nonsegmental vitiligo, a chronic autoimmune disease characterized by patchy loss of skin color from the progressive destruction of pigment-producing cells known as melanocytes.

Vitiligo not only affects physical health but also threatens quality of life. It can make employment more difficult and increase the risk of psychosocial health conditions, such as depression. In the EU, European Economic Area countries and United Kingdom, diagnosed vitiligo prevalence is estimated to be about 1.5 million patients, according to the company, with approximately 80% living with nonsegmental vitiligo.

Ruxolitinib, a Janus kinase (JAK) inhibitor, is the first and only approved treatment in the European Union that supports repigmentation in eligible patients with nonsegmental vitiligo.

According to drugmaker Incyte, a study of the drug resulted in significant improvements in facial and total body repigmentation, while there were no serious treatment-related adverse events reported related to use of the ruxolitinib cream. The company notes that satisfactory repigmentation may take more than 6 months of treatment.

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