Incyte announces the EMA validation of the MAA for ruxolitinib cream as a potential treatment for vitiligo.

The validation of the MAA by the European Medicines Agency (EMA) confirms that the submission is ready to enter the formal review process.

The MAA is supported by data from the Phase III TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream in more than 600 people (age >12 years) with vitiligo. Results from the Phase III program, recently presented at the 30th European Academy of Dermatology and Venereology (EADV) congress during a late-breaking research session, showed significant improvements in facial and total body repigmentation at 24 weeks of treatment with ruxolitinib cream in people with vitiligo. In the TRuE-V studies, patients using ruxolitinib cream did not report clinically significant application site reactions, and the overall safety profile was consistent with previous study data.