FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age

• ZORYVE cream provides rapid relief, with efficacy, safety, and tolerability demonstrated up to 56 weeks of treatment
• ZORYVE cream rapidly and significantly reduces itch, the most bothersome symptom of atopic dermatitis (AD)
• Once-daily cream is for use anywhere on the body for any duration
• AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States
• Third FDA approval for Company in two years
• Commercial product expected to be available by the end of July

WESTLAKE VILLAGE, Calif., July 09, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch and has been specifically developed to be a treatment option for long-term disease control.

“The chronic nature of AD coupled with the disease instability often leaves patients and caregivers feeling that they are constantly chasing their AD flares,” said 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. “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. 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.”

“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. “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.”

AD is the most common form of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. Itching (pruritus) is the most burdensome symptom and is the result of skin barrier dysfunction and neuroimmune dysregulation. In clinical trials, ZORYVE cream 0.15% showed rapid, significant, and sustained reduction in itch as soon as 24 hours following the first application. ZORYVE is a next-generation topical phosphodiesterase 4 (PDE4) inhibitor. PDE4 inhibitors can have a direct effect on the itch-signaling nerves of the skin, as well as the inflammatory pathways.

“People suffering from AD experience intense itch, rash, and sensitive skin, which warrant effective, safe, and well-tolerated treatments,” said Jonathan Silverberg, MD, PhD, MPH, professor of dermatology, and the director of clinical research and director of contact dermatitis at The George Washington University School of Medicine and Health Sciences in Washington, D.C. “ZORYVE was developed with the AD patient in mind, to deliver the drug in a moisturizing vehicle that is formulated without common sensitizers or irritants and does not further disrupt the abnormal skin barrier. It’s also important to note that in clinical trials ZORYVE monotherapy provided safe and effective long-term disease control to AD patients.”

“Today marks the third FDA approval of a commercial product for Arcutis in just the last two 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. “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.”

Arcutis intends to make ZORYVE cream 0.15% widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of July. The Company is dedicated to ensuring predictable access for the ZORYVE portfolio of products, with one simple copay and fulfillment process. The ZORYVE^® Direct Program helps patients access their prescribed Arcutis medication. Specifically, this patient support program helps those who have been prescribed ZORYVE to navigate the payer process, assists patients with adherence, and includes the ZORYVE Direct Savings Card Program, which can help reduce out-of-pocket costs for eligible commercially insured patients.^† Arcutis will also continue to offer the Arcutis Cares^TM patient assistance program (PAP) that provides ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.^‡

Clinical Data

The sNDA is supported by positive results from three Phase 3 studies, as well as a Phase 2 dose-ranging study, and two Phase 1 pharmacokinetic studies. INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) were two identical Phase 3, parallel group, double-blind, vehicle-controlled trials evaluating the safety and efficacy of ZORYVE cream 0.15% or vehicle applied once daily for four weeks to 1,337 adults and children 6 years of age and older with mild to moderate AD.

The INTEGUMENT-1 and -2 studies 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 plus a 2-grade improvement from baseline at Week 4 (INTEGUMENT-1: 32.0% ZORYVE cream vs. 15.2% vehicle, P<0.0001; INTEGUMENT-2: 28.9% ZORYVE cream vs. 12.0% vehicle, P<0.0001). In both studies, approximately 40% of children and adults treated with ZORYVE cream achieved a vIGA-AD score of Clear (0) or Almost Clear (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 as early as Week 1 (P<0.0001).

Rapid and significant improvement in itch was observed in individuals treated with ZORYVE cream within 24 hours of the first application, as measured by the change from baseline in daily Worst Itch-Numeric Rating Scale (WI-NRS) scores and compared with vehicle (nominal P<0.05). In addition, over 30% of individuals treated with ZORYVE cream in each study achieved WI-NRS Success at Week 4 (INTEGUMENT-1: 33.6% vs 20.7% P<0.01; INTEGUMENT-2: 30.2% vs 12.4% P<0.01), with significant improvements seen as early as Week 1. WI-NRS Success is defined as achievement of at least a 4‑point reduction on the WI-NRS 0-10 scale (in individuals 12 and older who had a baseline WI-NRS score of at least 4).

In addition, more than 40% of children and adults treated with ZORYVE cream achieved a 75% reduction 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). Significant improvements based on EASI-75 were observed with ZORYVE cream compared to vehicle as early as Week 1 in both studies (nominal P=0.0006; nominal P=0.0329).

ZORYVE cream 0.15% was well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low in both active treatment and vehicle arms, with most TEAEs assessed as mild to moderate in severity. There were no adverse reactions in the combined Phase 3 pivotal trials that occurred in more than 2.9% of subjects in either arm. The most common adverse reactions included headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The INTEGUMENT-OLE open-label study enrolled 658 participants who rolled over from INTEGUMENT-1 or -2. At any time after 4 weeks, INTEGUMENT-OLE participants who achieved a vIGA-AD score of Clear (0) with once-daily application switched to twice-weekly application (130 participants; 19.8% of study population). All other participants continued once-daily application. After participation in the INTEGUMENT studies for 28 and 56 weeks, 61.3% and 65.7% of participants achieved EASI-75 respectively.

A Media Snippet accompanying this announcement is available by clicking on this link.

About Atopic Dermatitis
AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States.

AD is a chronic, relapsing inflammatory skin disease that is genetically pre-disposed and presents across the lifespan. The disease appears as a red, intensely itchy rash that can occur anywhere on the body and may present differently in children and adults. AD presentation can rapidly fluctuate and vary based on geographic location and environment.

About ZORYVE^®
ZORYVE is a steroid-free topical PDE4 inhibitor approved to treat AD, seborrheic dermatitis, and plaque psoriasis. PDE4 — an established target in dermatology — is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators.

ZORYVE (roflumilast) cream 0.15% is approved by the FDA for the treatment of mild to moderate atopic dermatitis in individuals 6 years of age and older and ZORVYE cream 0.3% for the topical treatment of plaque psoriasis in individuals 6 years of age and older. Another formulation, ZORYVE foam 0.3%, is available for the treatment of seborrheic dermatitis in adults and children ages 9 and older.

Roflumilast cream for AD is currently being evaluated at a lower dose of 0.05% for children aged 2 to 5 years. In addition, Arcutis has completed its clinical development program for ZORYVE foam 0.3% for the treatment of scalp and body psoriasis and intends to submit an sNDA in the third quarter of 2024.

INDICATIONS

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION

ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA-approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.

Forward-Looking Statements
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential of real-world use results of roflumilast cream in AD, the potential for roflumilast cream to advance the standard of care in AD and other inflammatory dermatological conditions, and the Company’s expected timing and plan to commercially launch ZORYVE cream 0.15% by the end of July. These statements are subject to substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, and the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

^{† Subject to eligibility criteria and maximum program limitation. This offer is not valid for patients without commercial drug insurance or whose prescription claims are eligible to be reimbursed, in whole or in part, by any government program.}

^‡ Subject to financial eligibility requirements. Other terms and restrictions apply.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com

Investors
Latha Vairavan, Vice President, Finance and Investor Relations
lvairavan@arcutis.com