RTTNews | Sep 21, 2021 11:31PM EDT

23:31 Tuesday, September 21, 2021 (RTTNews.com) - The U.S. Food and Drug Administration has approved Incyte Corp.'s (INCY) Opzelura or ruxolitinib cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis 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 approval was based on data from the TRuE-AD clinical trial program, consisting of two randomized, double-blind, vehicle-controlled Phase 3 studies evaluating the safety and efficacy of Opzelura in more than 1,200 adolescents and adults with mild to moderate atopic dermatitis.

Results from the studies showed patients experienced significantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily (BID), compared to non-medicated cream.

Atopic dermatitis is a chronic skin disease affecting more than 21 million people aged 12 years and older in the U.S. and is characterized by inflammation and itch. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust.

Read the original article on RTTNews ( https://www.rttnews.com/3227287/fda-approves-incyte-s-opzelura-cream-to-treat-atopic-dermatitis.aspx)

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