Incyte Receives CHMP Support for Opzelura Cream
Incyte announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending the approval of Opzelura cream for the treatment of moderate atopic dermatitis in adult patients for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate. The positive CHMP opinion is based on results from the pivotal Phase 3 TRuE-AD4 study, supported by the Phase 3 TRuE-AD1 and TRuE-AD2 studies, evaluating the safety and efficacy of ruxolitinib cream in adults with AD