Arcutis Offers Update on Application for Roflumilast Cream 0.15% with FDA

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Arcutis Biotherapeutics announced the update and indicated the FDA was working to finalize the action letter on July 09, 2024, which was 2 days after the assigned PDUFA date of July 07, 2024.

Arcutis Biotherapeutics, Inc., has announced an update regarding their supplemental New Drug Application (sNDA) for roflumilast cream 0.15% for the treatment of atopic dermatitis in individuals aged 6 years and older from the US Food and Drug Administration.

According to the announcement, the FDA indicated they are working to finalize the action letter and have not indicated they would extend the Prescription Drug User Fee Act (PDUFA) goal date of July 7, 2024. The company submitted the sNDA in September 2023 following positive findings from the INTEGUMENT studies. In these findings, roflumilast cream administered once per day led to rapid clearance of patients’ atopic dermatitis and major reductions in itch within only 24 hours.1,2

“We would like to emphasize that the FDA has not requested any additional information related to our sNDA. This speaks to the completeness and quality of our submission, as we have worked diligently to provide all necessary data and meet all regulatory requirements,” said Frank Watanabe, president and CEO of Arcutis.1 “We are in close contact with the FDA and anticipate receiving our action letter soon. Pending approval, we look forward to delivering this new innovative treatment in roflumilast cream to the millions suffering from atopic dermatitis.”

The steroid-free, topical treatment option is a potent and selective phosphodiesterase-4 (PDE4) inhibitor which is formulated to be both non-greasy and quickly-absorbed. Specifically, it is designed without being disruptive to the skin barrier and without common irritants, allowing the drug to function with patients reporting sensitive skin.2

The submission of Arcutis’s sNDA for roflumilast came on the heels of INTEGUMENT-1 and INTEGUMENT-2, a set of phase 3 trials assessing the drug’s use among patients with atopic dermatitis aged 6 and older. Both studies achieved their primary endpoint of Investigator Global Assessment - Atopic Dermatitis (vIGA-AD) score, indicating the medication’s efficacy in reduction of symptoms.2

The long-term, open-label INTEGUMENT-OLE study assessing roflumilast cream 0.15% found the agent to be both efficacious and well-tolerated. The INTEGUMENT-OLE investigators found 66.2% of subjects achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) by the 56-week mark.2


  1. Arcutis Biotherapeutics, Inc. Arcutis provides update on sNDA for roflumilast cream 0.15% for atopic dermatitis. GlobeNewswire News Room. July 9, 2024. Accessed July 9, 2024.
  2. Borgt J van der. Arcutis submits roflumilast cream 0.15% supplemental new drug application to the FDA for the treatment of atopic dermatitis in adults and children ages 6 years and older. Arcutis Biotherapeutics. September 12, 2023. Accessed July 9, 2024.