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Arcutis’ ZORYVE® (roflumilast) Awarded Best Eczema Treatment by Glamour

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Arcutis Biotherapeutics' ZORYVE® (roflumilast) cream 0.15% has received Glamour's 2024 Health and Wellness award for Best Eczema Product in the Best Beauty Innovators category. ZORYVE is the first FDA-approved once-daily topical treatment for mild to moderate atopic dermatitis in patients aged 6 and older. The treatment, approved in July 2024, is a next-generation topical PDE4 inhibitor that can be applied anywhere on the body for any duration. Atopic dermatitis, the most common type of eczema, affects approximately 9.6 million children and 16.5 million adults in the United States.

ZORYVE® (roflumilast) crema 0,15% di Arcutis Biotherapeutics ha ricevuto il premio Glamour 2024 per la Salute e il Benessere come Miglior Prodotto per l'Eczema nella categoria delle Migliori Innovazioni di Bellezza. ZORYVE è il primo trattamento topico approvato dalla FDA con una somministrazione quotidiana per la dermatite atopica da lieve a moderata in pazienti di età pari o superiore a 6 anni. Questo trattamento, approvato a luglio 2024, è un inibitore della PDE4 di nuova generazione che può essere applicato ovunque sul corpo per qualsiasi durata. La dermatite atopica, il tipo più comune di eczema, colpisce circa 9,6 milioni di bambini e 16,5 milioni di adulti negli Stati Uniti.

ZORYVE® (roflumilast) crema 0,15% de Arcutis Biotherapeutics ha recibido el premio de Salud y Bienestar Glamour 2024 como el Mejor Producto para el Eccema en la categoría de Mejores Innovadores de Belleza. ZORYVE es el primer tratamiento tópico aprobado por la FDA que se aplica una vez al día para la dermatitis atópica leve a moderada en pacientes de 6 años y mayores. Este tratamiento, aprobado en julio de 2024, es un inhibidor de PDE4 de nueva generación que puede aplicarse en cualquier parte del cuerpo por cualquier duración. La dermatitis atópica, el tipo más común de eccema, afecta a aproximadamente 9,6 millones de niños y 16,5 millones de adultos en los Estados Unidos.

Arcutis Biotherapeutics의 ZORYVE® (로플루미라스트) 크림 0.15%가 Glamour 2024 건강 및 웰빙 상에서 최고의 피부염 제품으로 선정되었습니다. ZORYVE는 6세 이상의 환자에서 경증에서 중증의 아토피 피부염을 위한 FDA 승인 최초의 하루 한 번 사용 가능한 국소 치료제입니다. 2024년 7월에 승인된 이 치료제는 신세대 국소 PDE4 억제제로 신체의 어느 부위에나 아무리 오랜 시간 동안이나 적용할 수 있습니다. 아토피 피부염은 가장 일반적인 피부염 유형으로, 미국에서 약 960만 명의 어린이와 1,650만 명의 성인이 영향을 받습니다.

ZORYVE® (roflumilast) crème 0,15% d'Arcutis Biotherapeutics a reçu le prix Glamour 2024 de la santé et du bien-être pour le meilleur produit contre l'eczéma dans la catégorie des meilleures innovations beauté. ZORYVE est le premier traitement topique approuvé par la FDA à utiliser une fois par jour pour la dermatite atopique légère à modérée chez les patients âgés de 6 ans et plus. Ce traitement, approuvé en juillet 2024, est un inhibiteur topique de la PDE4 de nouvelle génération qui peut être appliqué n'importe où sur le corps pour n'importe quelle durée. La dermatite atopique, le type d'eczéma le plus courant, touche environ 9,6 millions d'enfants et 16,5 millions d'adultes aux États-Unis.

ZORYVE® (Roflumilast) Creme 0,15% von Arcutis Biotherapeutics hat den Glamour Health and Wellness Award 2024 in der Kategorie Beste Schönheitsexperimente als bestes Eczemprodukt gewonnen. ZORYVE ist die erste von der FDA zugelassene topische Behandlung zur einmal täglichen Anwendung bei leichter bis moderater atopischer Dermatitis bei Patienten ab 6 Jahren. Die Behandlung, die im Juli 2024 genehmigt wurde, ist ein next-generation topischer PDE4-Hemmer, der überall am Körper und über beliebige Zeitdauer angewendet werden kann. Atopische Dermatitis, die häufigste Form von Ekzem, betrifft in den Vereinigten Staaten etwa 9,6 Millionen Kinder und 16,5 Millionen Erwachsene.

Positive
  • Received prestigious industry award, potentially boosting brand recognition
  • Product addresses large market with 26.1 million potential patients in the US
  • First FDA-approved once-daily topical treatment in its category
Negative
  • None.

Insights

While receiving a Glamour award is a positive recognition, it has minimal impact on ZORYVE's commercial prospects or Arcutis' financial performance. The key value drivers remain the product's FDA approval for atopic dermatitis treatment and its market penetration in a sizeable addressable market of 26.1 million patients in the U.S.

The product's unique formulation without irritants and its once-daily application convenience are meaningful differentiators in the topical eczema treatment space. However, actual prescription trends, insurance coverage and revenue generation will be more significant indicators of commercial success than industry awards.

  • ZORYVE cream 0.15% is the first once-daily, Food and Drug Administration (FDA)-approved topical treatment for mild to moderate atopic dermatitis
  • ZORYVE, a next-generation topical phosphodiesterase-4 (PDE4) inhibitor, recognized for redefining topical treatment drug delivery for immune-mediated skin diseases and for its proprietary formulation

WESTLAKE VILLAGE, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- 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.

INDICATION
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. 

IMPORTANT SAFETY INFORMATION
ZORYVE 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 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 LinkedInFacebookInstagram, 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 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:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

Investors
Latha Vairavan, Vice President, Finance and Corporate Controller
ir@arcutis.com


FAQ

When did ZORYVE (ARQT) receive FDA approval for atopic dermatitis treatment?

ZORYVE received FDA approval in July 2024 for the treatment of mild to moderate atopic dermatitis in individuals ages 6 and older.

What is the market size for ZORYVE's (ARQT) atopic dermatitis treatment?

The market includes approximately 26.1 million potential patients in the United States, comprising 9.6 million children and 16.5 million adults with atopic dermatitis.

What award did ZORYVE (ARQT) win from Glamour in 2024?

ZORYVE won Glamour's 2024 Health and Wellness award for Best Eczema Product in the Best Beauty Innovators category.

Arcutis Biotherapeutics, Inc.

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WESTLAKE VILLAGE