FDA Approves Roflumilast Cream 0.15% for Atopic Dermatitis in Pediatric, Adult Patients


The commercial product is expected to be available by the end of July.

The FDA has approved the supplemental new drug application (sNDA) for roflumilast cream, 0.15% (Zoryve) for the treatment of mild to moderate atopic dermatitis (AD) in adult and pediatric patients aged 6 years and older, Arcutis Biotherapeutics announced in a news release.1 The cream provides rapid disease clearance and significant reduction in itch to patients and has been specifically formulated for long-term disease control.

Closeup of atopic dermatitis on hands / Ольга Тернавская - stock.adobe.com

Closeup of atopic dermatitis on hands / Ольга Тернавская - stock.adobe.com

“Today marks the third FDA approval of a commercial product for Arcutis in just the last 2 years, and we are thrilled to be able to offer Zoryve cream 0.15% as a new steroid-free treatment option to children and adults living with AD. With Zoryve, our goal has been to provide a steroid-free topical that can provide effective and fast results, wherever on the body it’s needed, and long-term disease control through a safe and tolerable formulation,” said Frank Watanabe, president and chief executive officer of Arcutis, in the release.1

Key Takeaways

  • Roflumilast cream 0.15% (Zoryve) is a new FDA-approved steroid-free treatment for mild to moderate AD in adults and children aged 6 years and older.
  • In clinical trials, over 40% of patients achieved clear or almost clear skin by week 4 using the medication.
  • Roflumilast cream appears to be safe and well-tolerated.

“Zoryve is the fastest-growing steroid-free topical, relied on to provide effective and safe results in any location on the skin for any duration. With the addition of the new 0.15% strength of Zoryve cream for AD to the higher-strength cream and foam products, the Zoryve portfolio has the potential to become the preferred topical brand in dermatology.”

The approval is supported by positive results from three phase 3 studies, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic studies.

Both the identical, phase 3, parallel group, double-blind, vehicle-controlled INTEGUMENT-1 (NCT04773600) and INTEGUMENT-2 (NCT04773600) trials evaluated the safety and efficacy of roflumilast cream 0.15%, or vehicle, applied once daily for 4 weeks to 1337 adults and children 6 years of age and older with mild to moderate AD.

Each met their primary endpoint of IGA Success, defined as a validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of Clear or Almost Clear and a 2-grade improvement from baseline at week 4 (NTEGUMENT-1: 32.0% Zoryve cream vs 15.2% vehicle, P <.0001; INTEGUMENT-2: 28.9% Zoryve cream vs 12.0% vehicle, P <.0001).

More than 40% of children and adults treated with roflumilast cream 0.15% achieved a vIGA-AD score of clear or almost clear at week 4 (INTEGUMENT-1: 41.5% vs 25.2%, P <.0001; INTEGUMENT-2: 39% vs 16.9%, P <.0001) with significant improvement as early as week 1 (P <.0001). Additionally, patients treated with roflumilast achieved significant improvements in the Eczema Area and Severity Index (EASI-75) compared to vehicle as early as week 1 in both trials (nominal P =.0006 and =.0329, respectively).

Roflumilast cream 0.15% was also demonstrated to be well tolerated,2 with most Treatment Emergent Adverse Events rated as mild to moderate in severity.

READ MORE: FDA Accepts sNDA for Tapinarof Cream 1% for Treatment of Atopic Dermatitis

“Zoryve rapidly improves and controls disease, including itch, the most bothersome reported symptom. In clinical trials, 9 in 10 patients saw some improvement at 4 weeks, with 69% of patients demonstrating a clinically meaningful improvement of at least an EASI-50,” said Lawrence F. Eichenfield, MD, INTEGUMENT study investigator, professor of dermatology and pediatrics and vice chair of the department of dermatology at UC San Diego School of Medicine, in the release.1 “In addition, Zoryve is a safe and effective steroid-free treatment option. Topical steroids have been the foundation of treatment for AD for the past 50 years. 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.”

Roflumilast cream 0.15% is expected to be widely available through wholesalers and dermatology pharmacy channels by the end of July. The ZoryveDirect Program will provide support to those prescribed the medication in navigating the payer process, promoting adherence, and reducing out-of-pocket costs for eligible commercially insured patients.1

AD is the most common type of eczema, affecting an estimated 30% of the US population.2 A next-generation topical phosphodiesterase 4 inhibitor, roflumilast cream 0.15% targets the itch-signaling nerves of the skin and inflammatory pathways to mitigate itching and discomfort associated with the condition.

“Living with AD, a chronic inflammatory skin disease, and the intense itching associated with it, can have a profound impact on quality of life and family dynamics for both adults and children,” said Wendy Smith Begolka, chief strategy officer at the National Eczema Association, in the release.1 “We are pleased to see new advancements and innovation in treatment for the millions of children and adults who are suffering with this serious skin disease.

READ MORE: Dermatology Resource Center

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1. FDA approves Arcutis’ Zoryve (roflumilast) cream 0.15% for the treatment of atopid dermatitis in adults and children down to 6 years of age. News release. Arcutis Biotherapeutics. July 9, 2024. Accessed July 10, 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#
2. 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. 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/
3. Eczema (atopic dermatitis). Fact sheet. National Institute of Allergy and Infectious Diseases. Accessed July 10, 2024. https://www.niaid.nih.gov/diseases-conditions/eczema-atopic-dermatitis
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