2023-04-20 11:32:46 ET
- The European Commission (EC) approved Incyte's ( NASDAQ: INCY ) Opzelura cream to treat non-segmental vitiligo with facial involvement in patients 12 years of age and older.
- The company said that Opzelura (ruxolitinib) is the first and only topical JAK inhibitor approved in the EU to help repigmentation in eligible patients with non-segmental vitiligo — a chronic autoimmune disease characterized by depigmentation of skin.
- The EC decision follows a recommendation of approval for the drug by a panel of the European Medicines Agency (EMA) in February.
- The approval was backed by data from two phase 3 trials called TRuE-V1 and TRuE-V2.
- Opzelura was approved for the same use in the U.S. in July 2022. The drug is also approved in the U.S. to treat certain patients with atopic dermatitis.
- Incyte has an agreement with Maruho Co. to develop and sell ruxolitinib cream to treat autoimmune and inflammatory dermatology conditions in Japan.
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Incyte's Opzelura for vitiligo wins approval in EU