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
- Roflumilast cream demonstrated statistically significant improvements over vehicle on primary and secondary endpoints in Phase 3 trials
- Roflumilast cream provided rapid clearance of the disease and reduced itch in as little as twenty-four hours
- Roflumilast cream is a once-daily, steroid-free, topical formulation with a favorable safety and tolerability profile
- None.
- Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States
- In pivotal Phase 3 trials, roflumilast cream demonstrated statistically significant improvements over vehicle on the primary endpoint of Investigator Global Assessment (IGA) Success at Week 4, as well as on key secondary endpoints including rapid improvement in itch
- Roflumilast cream was well tolerated and demonstrated a favorable safety and tolerability profile during up to 56 weeks of treatment
WESTLAKE VILLAGE, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream
“Atopic dermatitis is a chronic and relapsing disease that occurs across the lifespan. In clinical studies, once-daily roflumilast cream provided rapid clearance of the disease. In addition, roflumilast cream rapidly reduced itch, one of the most bothersome symptoms to patients, in as little as twenty-four hours,” said Eric Simpson, MD, MCR, FAAD, Professor of Dermatology at Oregon Health & Science University in Portland, Oregon, and investigator in the Phase 3 INTEGUMENT trials. “The INTEGUMENT studies’ novel approach also incorporated assessment of twice weekly proactive treatment in the long-term study, which demonstrated that, once clear, patients could maintain adequate control by staying ahead of the condition rather than chasing flares. Together, these data suggest that roflumilast cream, if approved, could provide a simplified approach to disease control.”
Roflumilast cream is a once-daily, steroid-free, topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor. Roflumilast cream is uniquely formulated with HydroARQ Technology™ as a non-greasy emollient cream that absorbs quickly and does not disrupt the skin barrier. In addition, roflumilast cream does not include sensitizing excipients or irritants, such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances.
“Atopic dermatitis is a complex disease. Optimal management of the condition requires a complex balance of treatment, efficacy, safety, tolerability, as well as adherence. Atopic dermatitis patients have sensitive skin and increased risk for developing contact dermatitis from their topical medications,” said Jonathan Silverberg, MD, PhD, MPH, FAAD, Professor, Director of Clinical Research, and Director of Patch Testing at George Washington University School of Medicine and Health Sciences, Washington, DC. “Topical roflumilast cream was intentionally formulated with the atopic dermatitis patient in mind, and does not contain excipients that disrupt skin-barrier integrity or are common contact allergens. Overall, once-daily topical roflumilast cream has demonstrated in clinical trials a balance of efficacy and tolerability, along with a long-term safety profile, that could support increased adherence for patients with atopic dermatitis.”
“Topical therapies are foundational therapy for the vast majority of individuals who use pharmaceuticals to treat their atopic dermatitis, but today’s topicals come with limitations. People suffering from atopic dermatitis want fast-acting, steroid-free, topical treatments that are effective and well tolerated,” said Frank Watanabe, President and Chief Executive Officer of Arcutis. “This is particularly important given the prevalence of the disease in children, where safety and tolerability are of particularly great concern when considering which treatment to use. Both healthcare professionals and patients or parents deserve to feel confident in the treatment decisions they make.”
“Today marks another critical milestone for Arcutis, with the third topical roflumilast submission in two years. I would like to thank the team at Arcutis for their incredible hard work and dedication,” added Watanabe.
About the Data
The sNDA submission is supported by positive results from the “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis” (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, parallel group, double blind, vehicle-controlled trials in which roflumilast cream
Both studies met the 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:
Over
In both studies, approximately
In addition, more than
Roflumilast cream
The submission is also supported by data from a Phase 2 dose ranging study, an open label extension study in which patients were treated for up to 52 weeks, and two Phase 1 pharmacokinetic studies.
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 characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms, and legs. The rash can cover significant areas of the body, in some cases half of the body or more. AD typically begins in early childhood and is chronic. It persists into adolescence and even adulthood in some individuals. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Since a large percentage of AD patients are children, safety is a particularly important consideration in treatment selection.
About Roflumilast Cream
Roflumilast cream is a next generation topical PDE4 inhibitor. 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. Roflumilast cream
About ZORYVE
ZORYVE (roflumilast) cream
IMPORTANT SAFETY INFORMATION
The use of ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
The most common adverse reactions in psoriasis subjects (≥
Please see full Prescribing Information.
About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 that harnesses 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, seborrheic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and Twitter.
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, among others, statements regarding the potential for roflumilast to be approved for the treatment of adults and children with AD, the potential to use roflumilast cream over a long period of time, or chronically, the potential to use roflumilast cream anywhere on the body, including the face and sensitive areas, the potential for roflumilast to advance the standard of care in AD and other inflammatory dermatologic conditions. 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, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 28, 2023, 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.
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