Roflumilast Cream Receives FDA Approval for Atopic Dermatitis

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This decision by FDA officials resulted from the INTEGUMENT study findings which determined that once-daily roflumilast led to rapid eczema clearance and significant disease reductions.

Roflumilast Cream Receives FDA Approval for Atopic Dermatitis

Arcutis Biotherapeutics, Inc., announced the US Food and Drug Administration has approved roflumilast cream 0.15% for the treatment of individuals aged 6 years and older with moderate-to-severe atopic dermatitis (AD).1,2

The company had submitted to FDA officials the drug’s supplemental New Drug Application (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.3

“The chronic nature of AD coupled with the disease instability often leaves patients and caregivers feeling that they are constantly chasing their AD flares,” Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice chair of the department of dermatology at UC San Diego School of Medicine and INTEGUMENT study investigator, said in a statement. “(Roflumilast) rapidly improves and controls disease, including itch, the most bothersome reported symptom...Having a new and effective steroid-free option, without some of the risks associated with topical and systemic steroids, is a welcome advancement for dermatologists, patients, and caregivers.”1

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.3

The submission of Arcutis’s sNDA for roflumilast had specifically followed the conclusion 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.

The long-term, open label INTEGUMENT-OLE study assessing roflumilast cream 0.15% for the treatment of mild to moderate disease looked at adults and children aged 6 years and older as well. The drug was again shown to be both efficacious and well-tolerated.

The INTEGUMENT-OLE investigators found that 66.2% of subjects had been successful in achieving a 75% improvement in Eczema Area and Severity Index (EASI-75) by the 56-week mark.

The INTEGUMENT studies had all involved the use of what was described as a novel approach involving an evaluation of patients using a twice-per-week proactive treatment. Previously, roflumilast was noted as representing a simpler approach to disease control.

Raj Chovatiya, MD, PhD, clinical associate professor of medicine for the Rosalind Franklin University of Medicine and Science, noted in an interview with HCPLive that there had been a broad use of topical corticosteroids previously, which he noted are themselves associated with various issues in terms of tolerability, longer-term use, or potency.

“We know that a lot of the medications we use are ointments, and this is actually an elegantly designed cream that really has tried to eliminate many of the emulsifiers that are quite irritating, along with some of the other components, like propylene-glycol, that have been issues for other topicals in the past,” Chovatiya explained. “So again, across age groups and especially in our kids, the ability to deliver something that's tolerable and easy to apply in a package that delivers efficacy is very important.”

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: June 9, 2024.
  2. 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. Published September 12. https://www.arcutis.com/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/.
  3. Smith T. Arcutis Announces Supplemental New Drug Application of Roflumilast for Atopic Dermatitis in Adults, Children. HCPLive. September 23, 2024. https://www.hcplive.com/view/arcutis-announces-supplemental-new-drug-application-roflumilast-for-atopic-dermatitis-in-adults-children. Date accessed: July 2, 2024
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