The Westlake Village, California-based company currently holds approval for Zoryve cream 0.05% in patients aged two and older. This expansion would target a significant patient population, as atopic dermatitis remains the most common form of eczema, with roughly 60% of affected children developing symptoms within their first year of life. Nationwide, the condition impacts approximately 9.6 million children and 16.5 million adults.
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Arcutis Seeks FDA Nod for Zoryve Use in Infants
The U.S. Food and Drug Administration is reviewing Arcutis Biotherapeutics’ application to expand the use of its Zoryve topical cream to infants as young as three months old. The agency has set a target action date of February 23, 2027, for the treatment of mild to moderate atopic dermatitis.
Beyond atopic dermatitis, Zoryve is already approved for plaque psoriasis and seborrheic dermatitis. The product has become a central pillar of the company’s portfolio, generating $105.4 million in net revenue during the first quarter of 2026.
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