Arcutis: FDA to Review Zoryve for Atopic Dermatitis in Infants
By Colin Kellaher
Arcutis Biotherapeutics said the U.S. Food and Drug Administration has accepted its application seeking expanded approval of its Zoryve topical treatment for infants with atopic dermatitis, the most common form of the skin condition eczema.
Arcutis said the FDA set a target action date of Feb. 23, 2027, for the application, which covers Zoryve cream 0.05% for the treatment of mild to moderate atopic dermatitis in infants ages 3 to 24 months.
The Westlake Village, Calif., biopharmaceutical company said atopic dermatitis, which affects about 9.6 million children and 16.5 million adults in the U.S., is often initially diagnosed during childhood, with up to 60% of children developing symptoms within their first year.
Formulations of Zoryve cream are already approved in the U.S. for the treatment of mild to moderate atopic dermatitis patients ages 2 and older.
Zoryve, which is also approved for uses in plaque psoriasis and seborrheic dermatitis, generated net product revenues of $105.4 million in the first quarter of 2026.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 08, 2026 08:41 ET (12:41 GMT)
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