FDA Grants Approval of Roflumilast Cream 0.3% for Psoriasis Patients Aged 6 to 11

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This announcement by Arcutis broadens the psoriasis drug’s indication and was done to help simplify management of the skin condition for younger patients as well.

An announcement was made by Arcutis Biotherapeutics, Inc. regarding the US Food and Drug Administration’s (FDA) approval of the company’s supplemental new drug application (sNDA) on roflumilast cream (ZORYVE) for plaque psoriasis in kids aged 6 - 11.1

The new FDA approval broadens the indication for roflumilast cream, 0.3%, allowing for its application in topical treatment of psoriasis, including intertriginous areas of the body, for children in the new age bracket.

The treatment is a steroid-free cream which is administered once daily, allowing for both efficacy and safety. The new approval may help to simplify the management of psoriasis in children, especially given that plaque psoriasis is the most common form of the skin disease in those aged 6 - 11.

Adelaide A. Hebert, MD, professor and chief of pediatric dermatology for McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann, addressed the new approval by the FDA in a recent statement.

“In clinical studies with ZORYVE in the pediatric population, efficacy was consistent with the pivotal Phase 3 DERMIS-1 and DERMIS-2 trial results in adults,” Hebert said in her statement. “In addition, ZORYVE was shown to be safe and well tolerated, an important consideration for managing plaque psoriasis, especially in children.”

The expanded indication's approval by the FDA was due to a 4-week study called Maximal Usage Systemic Exposure (MUSE) that had involved subjects aged 6 - 11 known to have psoriasis. The data drawn from MUSE aligned generally with the results of the pivotal Phase 3 trials, DERMIS-1 and DERMIS-2, on adult patients.

President and CEO of the National Psoriasis Foundation Leah M. Howard, JD, addressed the agency’s decision as well.

“We are told by the experts that advise us that there are numerous challenges when it comes to treating children, and finding the right treatment regimen can be difficult, which is why we are encouraged by the advancements being made to alleviate the burden of disease for this population,” Howard said in a statement.

In the coming months, the FDA is set to review results from a second MUSE study involving children in the 2 - 5 age range and the data resulting from an ongoing open-label extension study on the long-term safety of roflumilast cream 0.3% for those with plaque psoriasis, aged 2 years and older.


  1. FDA approvesArcutis’ ZORYVE (roflumilast) cream 0.3% for the treatment of psoriasis in children ages 6 to 11. Arcutis Biotherapeutics. News release. October 6, 2023. Date accessed: October 6, 2023.