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September 21, 2021September 21, 2021 – OpzeluraTM (ruxolitinib) cream, manufactured by Incyte, has won U.S. FDA approval to treat mild to moderate atopic dermatitis in non-immunocompromised patients ages 12 years and up.
- Indicated for short-term and non-continuous chronic treatment, Opzelura is approved only for use in patients whose disease is not adequately controlled with other topical prescription therapies or for whom those therapies are inadvisable. It is the first topical formulation in a drug class known as JAK inhibitors to receive FDA approval.
- Recommended dosing is a thin layer applied to affected areas of the skin twice daily. The cream should not be used on more than 20% of the body surface and no more than 60g should be used per week.
- Opzelura has a wholesale acquisition cost (WAC) of $1,950 per 60g tube.