ARQT Arcutis Biotherapeutics Inc

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis’ ZORYVE® (roflumilast) cream 0.15% has received Glamour’s 2024 Health and Wellness award for Best Eczema Product. The Best Beauty Innovators category acknowledges breakthrough innovations from the past year.

“This prestigious award from Glamour is a testament to the exceptional work of our research and development and technical operations teams to formulate ZORYVE, a highly selective and potent PDE4 inhibitor. As a result, ZORYVE is an effective, well tolerated, moisturizing topical that can be applied anywhere on the body for any duration. ZORYVE delivers its active ingredient in a formulation that is free of any excipients, irritants, or sensitizers that could further compromise a patient’s skin barrier, which is critical for chronic skin conditions like eczema,” said Frank Watanabe, president and CEO of Arcutis.

Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. ZORYVE cream 0.15% was approved by the FDA for the treatment of mild to moderate atopic dermatitis in individuals ages 6 and older in July 2024.

About ZORYVE®ZORYVE (roflumilast) is a potent and selective 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. ZORYVE is the first and only branded topical therapy for three major inflammatory dermatoses.

ZORYVE is uniquely formulated as an emollient, water-based product without fragrances or penetration enhancers, which are commonly used in prescription topicals that can irritate the skin and cause local tolerability issues. Arcutis’ formulations are also pH balanced to the skin and contain moisturizing properties.

INDICATIONZORYVE 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. 

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

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%).

Please see full Prescribing Information for ZORYVE.

ZORYVE is for topical use only and not for ophthalmic, oral, or intervaginal use.

About ArcutisArcutis 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 StatementsArcutis 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 that clinical trial results will translate to real-world use of ZORYVE cream and the potential for ZORYVE cream to advance the standard of care in atopic dermatitis and other inflammatory dermatological 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 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.

Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com

InvestorsLatha Vairavan, Vice President, Finance and Corporate Controllerir@arcutis.com