Incyte's Topical JAK Inhibitor Scores FDA Approval For Atopic Dermatitis
- The FDA has approved Incyte Corporation's (NASDAQ: INCY) Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD).
- Also Read: FDA Hits JAK inhibitors With Heart Safety, Cancer Warnings: All You Need To Know.
- 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.
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