Arcutis awaits FDA decision for roflumilast cream 0.15% to treat AD

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The decision target action date was July 7, 2024. At this time, there is no indication from the federal agency to extend the date further.

Arcutis awaits FDA decision for roflumilast cream 0.15% to treat AD | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

Arcutis awaits FDA decision for roflumilast cream 0.15% to treat AD | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

An FDA decision on the supplemental New Drug Application (sNDA) for roflumilast cream 0.15%—to treat mild to moderate atopic dermatitis (AD) in adults and children down to 6 years of age—has yet to come despite the passing of the July 7, 2024, Prescription Drug User Fee Act (PDUFA) date.1

According to an update from roflumilast's manufacturer, Arcutis Biotherapeutics, the federal agency is working to finalize the action letter, and have "not indicated" they would extend the original PDUFA date.1

"We would like to emphasize that the FDA has not requested any additional information related to our sNDA," said Frank Watanabe, president and CEO, Arcutis. "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. 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.”1

The July 7, 2024, target action date was set when the FDA accepted the sNDA for roflumilast cream 0.15% on November 29, 2023, based on positive results from 2 phase 3 trials, INTEGUMENT-1 (NCT04773587) and INTEGUMENT-2 (NCT04773600).2

Roflumilast met its primary outcome of an Investigator Global Assessment–Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1), plus a 2-grade improvement from baseline at week 4 (INTEGUMENT-1: 32% roflumilast cream vs 15.2% vehicle [P < 0.0001]) and (INTEGUMENT-2: 28.9% roflumilast cream vs 12% vehicle [P < 0.0001]).2

In June 2024, Arcutis announced positive data from the INTEGUMENT-OLE open-label, long-term extension study. The once-daily, investigational topical cream is well tolerated with no new safety signals through 56 weeks of treatment in adult and children aged 6 years and older with AD, as 56.6% of participants who continued roflumilast cream 0.15% from the initial trial achieved vIGA-AD success. In addition, 53.8% of participants who switched to roflumilast cream 0.15% from vehicle after the intimal trial achieved vIGA-AD success, according to a press release from Arcutis, with data presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference (RAVE).3

"Looking for newer nonsteroidal agents that can bring efficacy and safety is something that's really important," said Lawrence Eichenfield, MD, when the sNDA for roflumilast was accepted.4

"Certainly, having those medicines approved down to younger ages is really important. The announcement of the FDA accepting the sNDA for roflumilast [0.15%], plus other work with that drug and other drugs, with different formulations and different agents, I think will be very important going forward to have a newer set of nonsteroidal medicines for AD," said Eichenfield in a previous interview with Contemporary Pediatrics.4

Contemporary Pediatrics' coverage of roflumilast cream 0.15% (Click each link below for more information):

Click here for more dermatology news.

References:

  1. Arcutis Provides Update on sNDA for Roflumilast Cream 0.15% for Atopic Dermatitis. Arcutis Biotherapeutics. Press release. July 9, 2024. Accessed July 9, 2024.
  2. Fitch, J. FDA accepts sNDA for roflumilast cream 0.15% to treat atopic dermatitis. Contemporary Pediatrics. November 29, 2023. Accessed July 9, 2024. https://www.contemporarypediatrics.com/view/fda-accepts-snda-for-roflumilast-cream-0-15-to-treat-atopic-dermatitis
  3. Fitch, J. New roflumilast cream 0.15% data demonstrate improvements in AD symptoms at 56 weeks. Contemporary Pediatrics. June 10, 2024. Accessed July 9, 2024. https://www.contemporarypediatrics.com/view/new-roflumilast-cream-0-15-data-demonstrate-improvements-atopic-dermatitis-symptoms-56-weeks
  4. Fitch, J. Lawrence Eichenfield, MD, reacts to accepted sNDA for roflumilast cream 0.15%. Contemporary Pediatrics. November 30, 2023. Accessed July 9, 2024. https://www.contemporarypediatrics.com/view/lawrence-eichenfield-md-reacts-to-accepted-snda-for-roflumilast-cream-0-15-
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