Incyte's Topical JAK Inhibitor Scores FDA Approval For Atopic Dermatitis

The FDA has approved Incyte Corporation's INCY Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD).
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The approval covers non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or those therapies are not advisable.
Opzelura is the first and only topical formulation of a JAK inhibitor approved in the U.S., the Company notes.
The approval was based on data from the TRuE-AD trial program, consisting of two Phase 3 studies (TRuE-AD1 and TRuE-AD 2) evaluating the safety and efficacy of Opzelura in more than 1,200 participants.
Results showed patients experienced significantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily, compared to vehicle (non-medicated cream).
Related content: Benzinga's Full FDA Calendar.
Price Action: INCY stock is down 2.18% at $74.40 during the premarket session on the last check Wednesday.