Roflumilast Cream 0.15% for Atopic Dermatitis Now Commercially Available

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Arcutis Biotherapeutics, Inc. has launched roflumilast (Zoryve) cream 0.15% for treating mild to moderate atopic dermatitis (AD) in adults and children down to the age of 6 in the US. The treatment, approved earlier this month, offers a steroid-free, once-daily option for managing AD. Roflumilast cream 0.15% is now available in pharmacies and is covered under 2 commercial pharmacy benefit manager (PBM) contracts, providing immediate insurance coverage for many patients.¹

“What is really unique about the profile of Zoryve cream is that it works quickly, but it’s also appropriate for long-term treatment. Oftentimes, we would have to go to 2 different therapies in order to address these different parts of the treatment. For an atopic dermatitis patient, it’s important that you work quickly because this is a disease that has a lot of itching and symptoms that need to be relieved,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, in a recent interview with Dermatology Times.²

Recent Approval Data

The FDA’s approval of Arcutis’ sNDA on July 9 was based on positive results from the three phase 3 INTEGUMENT clinical trials, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic studies. INTEGUMENT-1 (NCT04773587) and INTEGUMENT-2 (NCT04773600) were 2 identical, parallel-group, double-blind, vehicle-controlled, phase 3 clinical trials evaluating the safety and efficacy of roflumilast cream 0.15% or vehicle applied once-daily to affected skin for 4 weeks in 1337 adult and pediatric patients aged 6 years and older with mild to moderate atopic dermatitis.³

In INTEGUMENT-1 and INTEGUMENT-2, each study met its primary end point of a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) and a 2-grade improvement from baseline at week 4 (INTEGUMENT-1: 32.0% roflumilast cream vs. 15.2% vehicle, P<0.0001; INTEGUMENT-2: 28.9% roflumilast cream vs. 12.0% vehicle, P<0.0001). In both studies, 40% of adult and pediatric patients treated with roflumilast cream achieved a vIGA-AD score of 0 or 1 at week 4 (INTEGUMENT-1: 41.5% vs. 25.2%, P<0.0001; INTEGUMENT-2: 39% vs. 16.9%, P<0.0001), with significant improvement seen as early as week 1 (P<0.0001).³

Over 40% of adult and pediatric patients treated with roflumilast cream achieved a 75% improvement in Eczema Area and Severity Index (EASI 75) at week 4 compared to vehicle (INTEGUMENT-1: 43.2% vs. 22.0%, P<0.0001; INTEGUMENT-2: 42.0% vs. 19.7%, P<0.0001). Patients treated with roflumilast also achieved significant improvements in EASI 75 compared to vehicle as early as week one in both INTEGUMENT studies.³

The Development

Todd Edwards, chief commercial officer at Arcutis, emphasized the comprehensive approach taken in developing roflumilast cream 0.15% "AD is a complex disease that affects tens of millions of adults and children in the United States. While topical therapies are often prescribed to treat this chronic disease, they come with limitations on duration of use or side effects that require careful management," he said in today’s press release.¹ 

The cream's formulation is particularly noteworthy for its absence of excipients that can disrupt the skin barrier, cause irritation, or lead to contact allergies. Rocco Serrao, MD, dermatologist at DOCS Dermatology in Dayton, Ohio, highlighted the cream's potential in achieving long-term disease control. "The yet-to-be-satisfied goal for AD treatment is the establishment of long-term disease control by a therapy that is well tolerated by patients and also effective in both reducing inflammation as well as the most burdensome symptom in AD – itch," he noted in a press release.¹

Ensuring Access

The launch of roflumilast cream 0.15% is supported by the Zoryve Direct Program, a patient support initiative that assists with navigating the payer process and offers a savings card to help reduce out-of-pocket costs for eligible patients with commercial insurance. Additionally, Arcutis'Arcutis Cares patient assistance program provides the medication at no cost for financially eligible patients who are uninsured or underinsured.¹

References

1. Arcutis launches ZORYVE® (roflumilast) cream 0.15% for the treatment of atopic dermatitis. News Release. Arcutis Biotherapeutics. July 29, 2024. Accessed July 29, 2024. https://www.arcutis.com/arcutis-launches-zoryve-roflumilast-cream-0-15-for-the-treatment-of-atopic-dermatitis/
2. Bader K. FDA approves roflumilast cream 0.15% for atopic dermatitis in patients aged 6 years and older. Dermatology Times. July 9, 2024. Accessed July 29, 2024. https://www.dermatologytimes.com/view/fda-approves-roflumilast-cream-0-15-for-atopic-dermatitis-in-patients-aged-6-years-and-older
3. Arcutis announces new long-term data of roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (ad) in adults and children down to age six presented at Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference. News release. Arcutis Biotherapeutics. June 10, 2024. Accessed July 29, 2024. https://www.arcutis.com/arcutis-announces-new-long-term-data-of-roflumilast-cream-0-15-for-the-treatment-of-mild-to-moderate-atopic-dermatitis-ad-in-adults-and-children-down-to-age-six-presented-at-revolutionizing-alopecia/