Arcutis Biotherapeutics' Psoriasis Cream Gets FDA Approval for Young Children
By Elias Schisgall
The Food and Drug Administration approved the use of Arcutis Biotherapeutics' Zoryve plaque psoriasis cream for children as young as age two.
The company on Monday said the FDA approved a supplemental New Drug Application to expand the indication for the 0.3% Zoryve cream. It had previously been approved to treat adults and children as young as age six.
The approval was based on a study evaluating the use of Zoryve in children younger than six, as well as safety data from an open-label extension study.
"Children with plaque psoriasis under age 6 have historically had few treatment options that are appropriate for long--term use, forcing families and clinicians to navigate care for a chronic, progressive skin condition with limited choices," Chief Executive Officer Frank Watanabe said.
"This seventh FDA approval for Zoryve in four years demonstrates Arcutis' commitment to delivering meaningful innovation to the youngest children and their families," he added.
Write to Elias Schisgall at elias.schisgall@wsj.com
(END) Dow Jones Newswires
June 29, 2026 19:30 ET (23:30 GMT)
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