Arcutis Biotherapeutics' (ARQT) Arcutis Canada unit said Thursday that Health Canada has approved Zoryve cream 0.05% to treat mild to moderate atopic dermatitis in children 2 to 5 years old.

The approval is based on data from a phase 3 trial, which met its primary and key secondary endpoints, showing improvements in disease severity, with benefits observed as early as week 1, the company said.

Trial results were well-tolerated through week 56, with treatment-emergent adverse events predominantly mild to moderate in severity, the company said.

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