The target action date for roflumilast cream 0.3% for plaque psoriasis in children 2 to 5 years is set for June 29, 2026.
The FDA has officially accepted the supplemental new drug application (sNDA) for roflumilast (Zoryve; Arcutis Biotherapeutics) cream 0.3%, moving the therapy closer to becoming the first topical phosphodiesterase-4 (PDE4) inhibitor approved for plaque psoriasis in children as young as 2 years. According to the announcement from Arcutis Biotherapeutics on November 17, 2025, the federal agency assigned a PDUFA target action date of June 29, 2026.1
“Plaque psoriasis in young children can be particularly challenging to manage, as it often affects sensitive areas such as the face and intertriginous skin," said Amy Paller, MD, MS, attending physician, dermatology, Walter J. Hamlin professor and chair of dermatology, professor of pediatrics, Northwestern University Feinberg School of Medicine, in a statement. "Effective and well-tolerated treatment options that are gentle enough for these areas are critical to support long-term disease control and improve quality of life for children and their families."1
“Today, there are very limited FDA-approved treatment options for plaque psoriasis for children under 6, who often present with disease on sensitive skin such as the face and intertriginous areas," said Adelaide Hebert, MD, at the time of sNDA submission. Hebert is a professor and chief of pediatric dermatology at UTHealth Houston.2
"There is a significant unmet need for nonsteroidal options that can effectively treat plaque psoriasis over the long term. If approved, investigational [roflumilast] cream could be an important first-line treatment option for children as young as age 2," Hebert added.
Roflumilast cream 0.3% is a once-daily, steroid-free topical that avoids sensitizing excipients such as propylene glycol, polyethylene glycol, ethanol, or fragrances.²
“This milestone brings us closer to helping families and clinicians caring for young children with plaque psoriasis," said Frank Watanabe, president and CEO of Arcutis, in a press release. "If approved, [roflumilast] cream 0.3% would be the first and only topical PDE4 inhibitor indicated for children as young as 2, offering a steroid-free option that delivers both efficacy and tolerability for this particularly vulnerable group."
Psoriasis affects nearly 9 million people in the United States, according to Arcutis, and in children, plaques commonly present in intertriginous and thin-skinned areas, compounding disease burden. Both the MUSE and long-term open-label studies provided supportive data for this potential age expansion, with long-term results showing “consistent favorable long-term safety and tolerability as well as persistence of efficacy across all age ranges studied," the company stated.1
Zoryve cream 0.3% is currently approved for plaque psoriasis in patients aged 6 years and older.2 Approval of this sNDA would lower the indicated age range by four years, marking a significant regulatory milestone for pediatric dermatology.
In the video above from October 7, 2025, Lawrence Eichenfield, MD; and Rocco Serrao, MD, discussed the expanded
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