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Arcutis Still Awaiting FDA Action for Roflumilast Cream 0.15% for AD

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Article

The planned PDUFA data was July 7, 2024.

Exterior view of the headquarters of US Food and Drug Administration
Image Credit: © Grandbrothers - stock.adobe.com

Arcutis Biotherapeutics recently provided an update on the delayed status of the FDA’s approval of roflumilast cream 0.15% for the treatment of patients aged 6 years and older with mild to moderate atopic dermatitis. Arcutis has been in communication with the FDA regarding its supplemental new drug application (sNDA) for roflumilast cream. According to the update, the FDA is working to finalize the action letter and did not indicate it will need to extend the Prescription Drug User Fee Act (PDUFA) goal date of July 7, 2024.1

“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, in the news update. “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 FDA accepted Arcutis’ sNDA in November 2023 based on positive safety and efficacy data from three phase 3 programs, including INTEGUMENT-1 and INTEGUMENT-2, a phase 2 dose-ranging study, and two phase 1 studies assessing the pharmacokinetics of the drug. The INTEGUMENT studies, both of which were identical, parallel-group, double-blinded, and vehicle-controlled studies, randomized 884 patients to roflumilast cream 0.15% and 453 patients to vehicle cream for once-daily treatment.2

“In clinical trials, roflumilast cream demonstrated rapid and sustained improvement in the signs and symptoms of disease, as well as long-term proactive disease control with twice weekly maintenance dosing. With this profile, patients will not need to make tradeoffs between long-term safety, efficacy, and tolerability. Roflumilast cream, if approved, has the potential to simplify the approach to disease control for children and adults,” said Lawrence Eichenfield, MD, in a previous news release from Arcutis. Eichenfield is the chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego; professor of dermatology and pediatrics, vice-chair of the department of dermatology at UC San Diego School of Medicine, and an INTEGUMENT investigator.2

References

  1. Arcutis provides update on sNDA for roflumilast cream 0.15% for atopic dermatitis. News release. Arcutis Biotherapeutics. July 9, 2024. Accessed July 9, 2024. https://www.arcutis.com/arcutis-provides-update-on-snda-for-roflumilast-cream-0-15-for-atopic-dermatitis/
  2. FDA accepts Arcutis’ supplemental new drug application for roflumilast cream 0.15% for the treatment of atopic dermatitis in adults and children down to age 6. Arcutis Biotherapeutics. November 29, 2023. Accessed July 9, 2024. https://investors.arcutis.com/news-releases/news-release-details/fda-accepts-arcutis-supplemental-new-drug-application
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