Arcutis submits Zorvye (roflumilast) cream 0.05% supplemental new drug application to the FDA for the treatment of children aged 2 to 5 with mild to moderate atopic dermatitis

Arcutis Biotherapeutics

16 December 2024 - Zorvye cream 0.05% provided meaningful disease clearance and rapid reduction in itch in pivotal trials.

Arcutis Biotherapeutics today announced the submission of a supplemental new drug application to the US FDA for Zorvye (roflumilast) cream 0.05%, a once daily, next generation phosphodiesterase 4 inhibitor, for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years old.

Read Arcutis Biotherapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Paediatrics , Dossier