The U.S. Food and Drug Administration (FDA) on Thursday approved Incyte Corporation’s (NASDAQ:INCY) announced Opzelura (ruxolitinib) cream 1.5% for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended.
The FDA approval of the supplemental New Drug Application (sNDA) for Opzelura was based on data from the pivotal Phase 3 TRuE-AD3 trial.
Also Read: Incyte Surges Past Expectations With Strong Q2, Boosts Guidance On Jakafi Demand
The TRuE-AD3 study met its primary endpoint with significantly more patients treated with Opzelura achieving Investigator’s Global Assessment-treatment success (IGA-TS), a measure of treatment efficacy, than patients treated with vehicle control (non-medicated cream).
In addition, a secondary endpoint of patients demonstrating at least a 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8 was also achieved.
In September 2021, the FDA approved Opzelura for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
The FDA approved Opzelura in July 2022 for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
INCY Price Action: Incyte shares were up 1.16% at $87.00 during premarket trading on Friday. The stock is trading near its 52-week high of $87.99, according to Benzinga Pro data.
Read Next:
Photo via Shutterstock
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
