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FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2

$ARQTPress releaseJun 29, 2026, 7:06 PM ETRead the release

Arcutis received FDA approval for a supplemental indication of ZORYVE cream 0.3%, expanding its use to treat plaque psoriasis in children as young as 2 years of age. The approval is supported by data from a 4-week maximal usage systemic exposure study and an open-label extension study demonstrating safety and efficacy profiles consistent with pivotal trials in older patients.

Key figures

Drug Name
ZORYVE (roflumilast) cream 0.3%

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    ARQT: FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2 — AI Analysis | Signal8