FDA Expands Indication for Non-Steroid Cream to Treat Psoriasis In Children as Young as 6 Years of Age


Roflumilast is the first topical agent indicated to treat psoriasis in sensitive intertriginous areas of the skin.

The FDA has approved a supplemental new drug application (sNDA) to expand the indication of steroid-free roflumilast (Zoryve; Arcutis Therapeutics Inc.) cream 0.3% to include the treatment of plaque psoriasis and intertriginous areas in children aged 6 to 11 years, according to an Arcutis press release. In children, psoriasis affects sensitive areas of thinner skin, so there is a need for treatment that is safe and well tolerated.

“Young children with plaque psoriasis lack treatment options, which is why today’s decision by the FDA represents a meaningful advancement for this pediatric population, their parents, and caregivers,” said Patrick Burnett, MD, PhD, FAAD, CEO at Arcutis, in a press release.

The most common standard-of-care treatment for pediatric psoriasis has been topical steroids, but long-term steroid use could be a risk to safety and tolerability, explained Adelaide A. Hebert, MD, professor, chief of pediatric dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann, in the press release. According to Herbert, there is a need for more steroid-free psoriasis treatments that can be used on sensitive areas of skin (i.e., skin folds), especially given the fact that more children have psoriasis in these areas compared to adults.

The FDA expanded roflumilast’s indication based on positive data collected from the Maximal Usage Systemic Exposure (MUSE) study, which evaluated the pharmacokinetic, safety, tolerability, and efficacy of roflumilast in children aged 6 to 11 years. Findings from MUSE were consistent with findings from the pivot phase 3 DERMIS-1/-2 studies. A second MUSE study evaluated roflumilast for young children aged 2 to 5 years, and findings will be submitted to the FDA for review.

Psoriasis is the number 2 most common inflammatory skin disease among children, explained Lead M. Howard, JD, president, and CEO of the National Psoriasis Foundation, in the press release, and is the most common immune-mediated skin disease in all the United States.

Most patients with psoriasis develop raised, inflamed areas of skin (plaques) covered with white/silver dead skin cells. Plaques can be itchy and painful, and those found on the face, elbows, knees, scalp, and intertriginous areas of rubbing skin (i.e., armpits or under the breasts) pose different challenges. The condition can significantly reduce quality of life for the patient, family, or caregiver, Howard said.

The most common adverse events (AEs) associated with roflumilast, which affected fewer than 4% of patients, were diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection.

This treatment is the first topical cream that is indicated to treat psoriasis in sensitive intertriginous areas of the skin. It does not include skin irritants like propylene glycol or fragrances, and experts are encouraged by results.

Burnett concluded, “We are excited to now be able to expand the availability of roflumilast to children as young as 6 years old, offering them and their families an important new steroid-free treatment option to consider along with their health care providers.”


FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11. Arcutis Biotherapeutics Inc. News Release. October 6, 2023. Accessed on October 6, 2023. https://www.globenewswire.com/news-release/2023/10/06/2756044/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-3-for-Treatment-of-Psoriasis-in-Children-Ages-6-to-11.html

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