FDA accepts sNDA for Arcutis’ Zoryve in young children with eczema

27 February 2025

Immuno-dermatology specialist Arcutis Biotherapeutics (Nasdaq: ARQT) closed Wednesday’s trading 8% higher.

The Californian company earlier announced the US Food and Drug Administration’s (FDA) acceptance of a supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream 0.05%, a once-daily, phosphodiesterase-4 (PDE4) inhibitor, for the topical treatment of mild to moderate atopic dermatitis (AD) in children aged two to five years old.

A PDUFA target action date has been set of October 13 for this application.

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