Roflumilast sNDA Accepted for Plaque Psoriasis in Patients 2 to 5 Years

The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) from Arcutis Biotherapeutics seeking to extend the indication for roflumilast cream 0.3% (ZORYVE) to include pediatric patients aged 2 to 5 years with plaque psoriasis.¹ The sNDA was submitted in early September, and a Prescription Drug User Fee Act (PDUFA) target action date is set for June 29, 2026.² If approved, this would become the first topical phosphodiesterase-4 (PDE4) inhibitor indicated for plaque psoriasis in this young pediatric population.

“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. “If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for children as young as two, offering a steroid-free option that delivers both efficacy and tolerability for this particularly vulnerable group. We remain deeply committed to advancing care for people of all ages living with immune-mediated skin diseases, offering innovative, advanced targeted topicals to elevate the standard of care—including children as young as age two.”¹

Addressing the Unmet Need

Plaque psoriasis affects nearly 9 million Americans and presents unique challenges in pediatric patients. Children more frequently exhibit involvement of sensitive or intertriginous sites, including the face, groin, axillae, and other areas where skin-to-skin contact complicates the use of many topical agents. Symptoms such as pruritus, pain, scaling, and erythema—or, on darker skin tones, grayish or purplish discoloration—can significantly impair quality of life for both young patients and their families.

“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, MS, MD, professor and chair of dermatology at Northwestern University Feinberg School of Medicine. “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

Clinical Evidence to Support Safety and Efficacy

The company’s submission is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 with plaque psoriasis (ARQ-151-306). According to Arcutis, the pediatric MUSE study demonstrated acceptable systemic exposure levels and a favorable safety profile.

In addition, the sNDA includes results from a long-term open-label study that enrolled participants across a broad pediatric age range, including those 2 to 5 years old. The long-term data showed sustained tolerability and persistence of efficacy over extended treatment durations. Across age groups, roflumilast cream demonstrated consistent safety signals, supporting its potential use as a chronic management option.

Looking Ahead

Roflumilast cream 0.3% is currently approved in adults and children aged 6 years and over. The once-daily, steroid-free cream addresses previous long-term treatment challenges and acts as an alternative to topical steroids and vitamin-D analogs. The non-greasy formula is the only topical indicated for intertriginous psoriasis and does not include propylene glycol, polyethylene glycol, ethanol, fragrances, or other sensitizing excipients or irritants. The topical foam version is approved for patients with plaque psoriasis 12 years of age and older.

If approved by the June 2026 PDUFA date, roflumilast cream 0.3% could meaningfully expand clinicians’ ability to manage plaque psoriasis in very young children, offering a once-daily, steroid-free, targeted therapy with demonstrated tolerability and sustained efficacy. The sNDA acceptance marks a potentially important step toward broadening treatment options for the youngest psoriasis patients—an area where safe, gentle, and effective therapies remain limited.

"Psoriasis in kids is on the rise, yet our treatment strategies for kids in preschool have not changed in decades. We need more options to treat plaque psoriasis in pediatric patients and we need them to be steroid-free, so I am so excited to see Arcutis pursue studies and indications for our littlest psoriasis patients," Lisa Swanson, MD, FAAD, pediatric dermatologist at Ada West Dermatology in Boise, Idaho, said in a recent interview with Dermatology Times.

References

1. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5. Globe Newswire. News release. Published November 17, 2025. Accessed November 17, 2025. https://www.globenewswire.com/news-release/2025/11/17/3189050/0/en/FDA-Accepts-Supplemental-New-Drug-Application-for-Arcutis-ZORYVE-roflumilast-Cream-0-3-for-the-Treatment-of-Plaque-Psoriasis-in-Children-Ages-2-to-5.html

2. Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5. Globe Newswire. News release. Published September 3, 2025. Accessed November 17, 2025. https://www.globenewswire.com/news-release/2025/09/03/3143886/0/en/Arcutis-Submits-Supplemental-New-Drug-Application-for-ZORYVE-roflumilast-Cream-0-3-to-Expand-Indication-for-Treatment-of-Plaque-Psoriasis-in-Children-Ages-2-to-5.html