Unmet Needs in Atopic Dermatitis and the Impact of Roflumilast Cream, with Raj Chovatiya, MD, PhD

Roflumilast is a therapeutic option for many patients with inflammatory conditions such as atopic dermatitis. It was approved by the US Food and Drug Administration (FDA) in 2024 as roflumilast cream 0.15% for individuals aged 6 years and older with moderate-to-severe atopic dermatitis.1

In February, the supplemental New Drug Application (sNDA) for roflumilast cream 0.05% was accepted by the FDA for mild to moderate atopic dermatitis in children aged 2 - 5 years old.2 To discuss the ways in which roflumilast could be addressing the unmet needs of patients with atopic dermatitis, the HCPLive team spoke with Raj Chovatiya, MD, PhD, clinical associate professor of medicine at Rosalind Franklin University Chicago Medical School and the founder and director of the Center for Medical Dermatology and Immunology Research in Chicago.

“Roflumilast cream has been a bit of a jack of all trades in recent years, as roflumilast itself has now piled up a few different indications: psoriasis in its cream form, seborrheic dermatitis in its foam form, and a slightly different concentration in the cream form for atopic dermatitis,” Chovatiya explained. “That already highlights a really important unmet need.”

Chovatiya noted that dermatologists will often encounter situations, however, in which the issue facing a patient is not obvious and a combination of conditions could be present.

“Think about special sites like the hands, inverse folds, and genitals, or even the face and scalp regions,” Chovatiya said. “So that's already one important place where roflumilast has already found a home. Additionally, roflumilast is an extraordinarily well-tolerated, very gentle, primarily water-composed cream that really works for people with sensitive atopic dermatitis and eczematous skin.”

Consequently, Chovatiya highlighted his belief that roflumilast, as a therapeutic for the treatment armamentarium, provides a nice head-to-toe treatment option that addresses the signs and symptoms of the disease in patients.

“In some of the longer-term data, what it showed was that for individuals who were able to get totally clear, they were actually able to go towards more proactive use a few times a week and prevent new flares for a medium time of many, many months,” Chovatiya said. “So I think for patients that are willing to go to the point of being very diligent on daily use and getting to the point of being well controlled, they may have the chance just to intermittently use the cream and then to be great.”

For additional information on roflumilast’s use among patients with atopic dermatitis, view the full interview clip above.

The quotes used in this interview summary were edited for clarity.

Chovatiya has reported serving as an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc, Regeneron, RAPT, Sanofi, Sitryx, and UCB.

References

1. FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age. Arcutis Biotherapeutics, Inc. June 9, 2024. https://www.globenewswire.com/en/news-release/2024/07/09/2910781/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-15-for-the-Treatment-of-Atopic-Dermatitis-in-Adults-and-Children-Down-to-6-Years-of-Age.html. Date accessed: May 7, 2025.

2. Arcutis Biotherapeutics. U.S. FDA accepts Supplemental New Drug Application For Arcutis’ ZORYVE® (roflumilast) cream 0.05% for the treatment of children aged 2 to 5 with mild to moderate atopic dermatitis. Arcutis Biotherapeutics. February 26, 2025. https://www.arcutis.com/u-s-fda-accepts-supplemental-new-drug-application-for-arcutis-zoryve-roflumilast-cream-0-05-for-the-treatment-of-children-aged-2-to-5-with-mild-to-moderate-atopic-dermatitis/. Date accessed: May 7, 2025.