Incyte announces additional FDA approval of Opzelura (ruxolitinib) cream in children ages 2-11 with atopic dermatitis

Incyte

18 September 2025 - Opzelura is the first topical Janus kinase inhibitor approved in the US for paediatric atopic dermatitis.

Incyte today announced that the US FDA has approved Opzelura (ruxolitinib) cream 1.5%, a topical Janus kinase inhibitor, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis 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.

Read Incyte press release

Michael Wonder

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Michael Wonder