Arcutis to Host ZORYVE® (Roflumilast) Cream 0.15% FDA Approval Call With KOL
Arcutis Biotherapeutics (Nasdaq: ARQT) has announced a virtual Key Opinion Leader (KOL) event to discuss the recent FDA approval of ZORYVE® (roflumilast) cream 0.15% for treating mild to moderate atopic dermatitis (AD) in adults and children aged 6 and above. The event, scheduled for July 29, 2024, at 8:30am ET, will feature a leading dermatology expert who will address the unmet needs and current treatment landscape for AD. The discussion will highlight ZORYVE's differentiating features and Arcutis' commercialization plans for this newly approved treatment. This event marks a significant milestone for Arcutis in the immuno-dermatology field, potentially impacting their market position and future revenue streams.
Arcutis Biotherapeutics (Nasdaq: ARQT) ha annunciato un evento virtuale con leader di opinione (KOL) per discutere la recente approvazione da parte della FDA della crema ZORYVE® (roflumilast) 0,15% per il trattamento della dermatite atopica (AD) da lieve a moderata negli adulti e nei bambini di età superiore ai 6 anni. L'evento, programmato per il 29 luglio 2024 alle 8:30 ET, presenterà un esperto di dermatologia che affronterà i bisogni insoddisfatti e l'attuale panorama dei trattamenti per l'AD. La discussione metterà in evidenza le caratteristiche distintive di ZORYVE e i piani di commercializzazione di Arcutis per questo nuovo trattamento approvato. Questo evento segna una tappa significativa per Arcutis nel campo dell'immuno-dermatologia, con potenziali ripercussioni sulla loro posizione di mercato e sui futuri flussi di entrate.
Arcutis Biotherapeutics (Nasdaq: ARQT) ha anunciado un evento virtual con Líderes de Opinión Clave (KOL) para discutir la reciente aprobación de la FDA de la crema ZORYVE® (roflumilast) 0.15% para tratar la dermatitis atópica (AD) leve a moderada en adultos y niños a partir de 6 años. El evento, programado para el 29 de julio de 2024 a las 8:30 a.m. ET, contará con un destacado experto en dermatología que abordará las necesidades no satisfechas y el panorama actual de tratamientos para la AD. La discusión resaltará las características diferenciadoras de ZORYVE y los planes de comercialización de Arcutis para este tratamiento recién aprobado. Este evento representa un hito importante para Arcutis en el campo de la inmuno-dermatología, lo que podría impactar su posición en el mercado y las futuras fuentes de ingresos.
Arcutis Biotherapeutics (Nasdaq: ARQT)는 성인과 6세 이상의 아동의 경증에서 중등증 아토피 피부염(AD) 치료를 위한 FDA의 ZORYVE® (로플루밀라스트) 크림 0.15% 승인에 대해 논의하는 가상 키 오피니언 리더(KOL) 이벤트를 발표했습니다. 2024년 7월 29일 오전 8:30 ET에 예정된 이 행사에는 아토피 피부염을 다루는 주요 피부과 전문가가 참석하여 AD에 대한 충족되지 않은 필요와 현재 치료 환경을 설명할 것입니다. 논의에서는 ZORYVE의 차별화된 특징 및 Arcutis의 상용화 계획을 강조합니다. 이 이벤트는 Arcutis에게 면역 피부과 분야에서 중요한 이정표가 되며, 향후 시장 위치와 수익원에 영향을 미칠 가능성이 있습니다.
Arcutis Biotherapeutics (Nasdaq: ARQT) a annoncé un événement virtuel avec des leaders d'opinion clés (KOL) pour discuter de la récente approbation par la FDA de la crème ZORYVE® (roflumilast) 0,15% pour traiter la dermatite atopique (AD) légère à modérée chez les adultes et les enfants de 6 ans et plus. L'événement, prévu le 29 juillet 2024 à 8h30 ET, présentera un expert en dermatologie qui abordera les besoins non satisfaits et le paysage actuel des traitements pour l'AD. La discussion mettra en lumière les caractéristiques distinctives de ZORYVE et les plans de commercialisation d'Arcutis pour ce traitement nouvellement approuvé. Cet événement marque une étape importante pour Arcutis dans le domaine de l'immuno-dermatologie, pouvant avoir un impact sur leur position sur le marché et leurs futures sources de revenus.
Arcutis Biotherapeutics (Nasdaq: ARQT) hat eine virtuelle Veranstaltung mit Key Opinion Leader (KOL) angekündigt, um die kürzliche FDA-Zulassung von ZORYVE® (Roflumilast) Creme 0,15% zur Behandlung von leichter bis mittelschwerer atopischer Dermatitis (AD) bei Erwachsenen und Kindern ab 6 Jahren zu erörtern. Die Veranstaltung, die für den 29. Juli 2024 um 8:30 Uhr ET geplant ist, wird einen führenden Hautpflegeexperten präsentieren, der auf die unerfüllten Bedürfnisse und die aktuelle Behandlungslandschaft für AD eingehen wird. Die Diskussion wird die differenzierenden Merkmale von ZORYVE und die Vermarktungspläne von Arcutis für diese neu zugelassene Behandlung hervorheben. Diese Veranstaltung markiert einen wichtigen Meilenstein für Arcutis im Bereich der immunologischen Dermatologie und könnte ihre Marktposition und zukünftigen Einnahmequellen beeinflussen.
- FDA approval of ZORYVE® cream 0.15% for atopic dermatitis treatment
- Expanded patient base including adults and children down to age 6
- Potential for increased market share in the atopic dermatitis treatment sector
- None.
WESTLAKE VILLAGE, Calif., July 22, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will host a virtual Key Opinion Leader (KOL) event featuring a leading dermatology and immune-mediated skin disease expert to discuss the unmet need and current treatment landscape for individuals with mild to moderate atopic dermatitis (AD). The event will highlight the differentiating features of and commercialization plans for ZORYVE® (roflumilast) cream
Details for the event are as follows:
Monday, July 29, 2024
8:30am ET
To register, click here.
Additional information may be accessed at the “Events” section of the Company’s website.
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
Roflumilast cream for AD is currently being evaluated at a lower dose of
INDICATIONS
ZORYVE cream,
ZORYVE cream,
ZORYVE foam,
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 (≥
The most common adverse reactions (≥
The most common adverse reactions (≥
Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream.
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
Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com
Investors
Latha Vairavan, Vice President, Finance and Investor Relations
lvairavan@arcutis.com
![](https://ml.globenewswire.com/media/N2NjZmViNDMtMTQ1MC00MzQ3LWIzZTktOGMwNTEwNzk0NDRkLTEyMDU2MDM=/tiny/Arcutis-Biotherapeutics-Inc-.png)
FAQ
What is the newly FDA-approved treatment by Arcutis (ARQT) for atopic dermatitis?
When is Arcutis (ARQT) hosting the KOL event to discuss ZORYVE® cream approval?
What topics will be covered in Arcutis' (ARQT) KOL event for ZORYVE® cream?