The approval stems from clinical evaluations conducted on children under six, supplemented by safety data derived from an open-label extension study. This 0.3% cream formulation offers a new avenue for families managing a chronic, progressive skin condition that has historically lacked long-term treatment options suitable for early childhood.
In section Market Quotes
FDA Clears Zoryve Psoriasis Cream for Toddlers
The Food and Drug Administration has authorized the use of Arcutis Biotherapeutics’ Zoryve plaque psoriasis cream for children as young as two years old. This regulatory green light expands the product’s label from its previous baseline of six years, widening the scope of available dermatological care for younger patients.
Chief Executive Officer Frank Watanabe described the move as a significant milestone, noting that this marks the seventh FDA approval for the Zoryve platform in four years. By lowering the age threshold, Arcutis aims to alleviate the burden on clinicians and parents who previously faced restricted medical choices for pediatric plaque psoriasis.
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