FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5
Arcutis (Nasdaq: ARQT) announced FDA acceptance of a supplemental NDA for ZORYVE cream 0.3% to expand the plaque psoriasis indication to children ages 2 to 5. The FDA set a PDUFA target action date of June 29, 2026. If approved, ZORYVE 0.3% would be the first topical PDE4 inhibitor indicated for children as young as two and would extend the current approval that covers ages six and up.
The submission is supported by a 4-week MUSE systemic exposure study and by long-term open-label safety and tolerability data showing persistence of efficacy across studied ages.
Arcutis (Nasdaq: ARQT) ha annunciato l'accettazione da parte della FDA di una NDA supplementare per crema ZORYVE 0.3% per espandere l'indicazione della psoriasi a placche ai bambini di età 2 a 5. La FDA ha fissato una data obiettivo di azione PDUFA del 29 giugno 2026. Se approvato, ZORYVE 0.3% sarebbe il primo inibitore topico di PDE4 indicato per i bambini di età pari o inferiore a due anni e amplierebbe l'attuale approvazione che copre i bambini dai sei anni in su.
La sottomissione è supportata da uno studio sistemico di esposizione 4-settimane MUSE e da dati di sicurezza e tollerabilità a lungo termine in open-label che mostrano la persistenza dell'efficacia nelle fasce di età studiate.
Arcutis (Nasdaq: ARQT) anunció la aceptación por la FDA de una NDA suplementaria para crema ZORYVE 0.3% para ampliar la indicación de psoriasis en placas a niños de 2 a 5 años. La FDA fijó una fecha objetivo de acción PDUFA de 29 de junio de 2026. Si se aprueba, ZORYVE 0.3% sería el primer inhibidor tópico de PDE4 indicado para niños de tan solo dos años y ampliaría la aprobación actual que cubre a partir de los seis años.
La presentación está respaldada por un estudio de exposición sistémica de 4 semanas MUSE y por datos de seguridad y tolerabilidad a largo plazo en open-label que muestran la persistencia de la eficacia en las edades estudiadas.
아쿗니스(나스닥: ARQT)은 ZORYVE 크림 0.3%의 보충 NDA를 FDA가 수용했다며, plaque psoriasis의 적응증을 2~5세 어린이로 확대한다. FDA는 PDUFA 목표 시점 날짜 2026년 6월 29일을 설정했다. 승인이 되면 ZORYVE 0.3%는 두 살 어린이까지도 사용 가능한 최초의 국소 PDE4 억제제가 되고, 현재의 6세 이상으로 확대되는 승인을 확장한다.
제출은 4주간의 전신 노출 연구인 MUSE와 연구 연령대 전반에 걸친 안전성 및 내약성의 장기 오픈레이블 데이터로 뒷받침되며, 효과의 지속성을 보여준다.
Arcutis (Bourse Nasdaq : ARQT) a annoncé l'acceptation par la FDA d'une NDA supplémentaire pour la crème ZORYVE 0,3% afin d'étendre l'indication du psoriasis en plaques chez les enfants âgés de 2 à 5 ans. La FDA a fixé une date cible PDUFA d'action au 29 juin 2026. Si approuvée, ZORYVE 0,3% serait le premier inhibiteur topique de PDE4 indiqué pour les enfants aussi jeunes que deux ans et étendrait l'approbation actuelle couvrant les enfants à partir de six ans.
La soumission est soutenue par une étude d'exposition systémique de 4 semaines MUSE et par des données de sécurité et de tolérance à long terme en open-label montrant la persistance de l'efficacité dans les tranches d'âge étudiées.
Arcutis (Nasdaq: ARQT) gab die FDA-Akzeptanz einer ergänzenden NDA für ZORYVE Creme 0,3% bekannt, um die Indikation der Plaque-P psoriasis für Kinder im Alter von 2 bis 5 Jahren zu erweitern. Die FDA setzte ein PDUFA-Zieltermindatum vom 29. Juni 2026 fest. Falls genehmigt, wäre ZORYVE 0,3% der erste topische PDE4-Inhibitor, der für Kinder so jung wie zwei Jahre angezeigt wäre, und würde die aktuelle Zulassung erweitern, die Kinder ab sechs Jahren abdeckt.
Die Einreichung wird von einer 4-wöchigen MUSE-systemischen Expositionsstudie sowie von langfristigen Open-Label-Sicherheits- und Verträglichkeitsdaten gestützt, die das Fortbestehen der Wirksamkeit über die untersuchten Altersgruppen zeigen.
أركوتيس (ناسداك: ARQT) أعلنت قبول إدارة الغذاء والدواء الأمريكية (FDA) لطلب NDA مكمل لـ كريم ZORYVE 0.3% بهدف توسيع مؤشر التهاب الجلد التأتبي اللويحي المزمن إلى الأطفال من العمر 2 إلى 5 سنوات. حددت FDA تاريخ هدف PDUFA للإجراء في 29 يونيو 2026. إذا تمت الموافقة، سيكون ZORYVE 0.3% أول مثبط موضعي لـ PDE4 متاح للأطفال حتى سن الثانية، وسيُوسع التأييد الحالي الذي يغطي الأطفال من سن ست سنوات فما فوق.
تستند المستندات إلى دراسة تعرّض منظمي لمدة 4 أسابيع MUSE إضافة إلى بيانات السلامة والتحمل طويلة الأجل في مفتوح التسمية تظهر استمرار الفعالية عبر فئات الأعمار المدروسة.
- FDA accepted sNDA with PDUFA date June 29, 2026
- Potential first topical PDE4 indication for ages 2–5
- Submission supported by a 4-week MUSE pediatric study
- Long-term open-label data show consistent safety and persistent efficacy
- sNDA acceptance is not approval; regulatory decision pending June 29, 2026
Insights
FDA acceptance of the sNDA and a
Arcutis gained FDA acceptance of a supplemental NDA to add children ages 2–5 to the plaque psoriasis indication for ZORYVE cream 0.3%. The submission rests on a 4-week Maximal Usage Systemic Exposure (MUSE) study in ages 2–5 and a long-term open-label study that included this age group, with reported consistent favorable long-term safety, tolerability, and persistence of efficacy.
The business mechanism is straightforward: regulatory approval would expand the addressable pediatric population by adding ages 2 to 5, creating a first-in-class topical PDE4 option for that cohort. Key dependencies include the FDA review outcome by the
Risks center on regulatory standards for pediatric safety and exposure. The submission duration and study types are stated facts; no efficacy magnitude or numeric safety rates are provided. Watch the FDA action on
- Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026
- If approved, ZORYVE cream
0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2
WESTLAKE VILLAGE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA acceptance of a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream
“Plaque psoriasis in young children can be particularly challenging to manage, as it often affects sensitive areas such as the face and intertriginous skin,” said Amy Paller, MS, MD, attending physician, dermatology, Walter J. Hamlin Professor and chair of dermatology, professor of pediatrics, Northwestern University Feinberg School of Medicine. “Effective and well-tolerated treatment options that are gentle enough for these areas are critical to support long-term disease control and improve quality of life for children and their families.”
“This milestone brings us closer to helping families and clinicians caring for young children with plaque psoriasis,” said Frank Watanabe, president and CEO of Arcutis. “If approved, ZORYVE cream
ZORYVE cream
About Plaque Psoriasis
Psoriasis is a common, chronic, inflammatory skin disease that affects nearly 9 million people in the United States. Symptoms include itch, scaling, redness, flaking, and pain. On darker skin tones, plaques may appear more grayish, purplish, or brown. Psoriasis can appear anywhere on the body, including the knees, elbows, torso and thin-skinned areas like the face, genitals and intertriginous areas, which are areas where skin touches skin, such as the armpits, under the breasts, stomach folds, between the buttocks, and in the groin. In children, psoriasis more commonly affects these sensitive areas and intertriginous regions, posing treatment challenges and quality-of-life burdens for patients and families.
About ZORYVE® (roflumilast)
ZORYVE is the number one prescribed branded topical therapy across three major inflammatory dermatoses combined—atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE cream is a topical formulation of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. Inhibiting PDE4, an intracellular enzyme that is an established target in dermatology, decreases the production of pro-inflammatory mediators. This decreases inflammation in the skin and balances the skin’s immune system.
Demonstrating both clinical impact and broad industry recognition, ZORYVE has been honored with multiple prestigious awards and recommendations. ZORYVE was recently awarded by Allure with the "2025 Best of Beauty Breakthrough Award," making it the first FDA-approved medication for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis to win this prominent award. 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 of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.
INDICATIONS
ZORYVE cream,
IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
The most common adverse reactions reported (≥
Please see full Prescribing Information for ZORYVE cream.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, 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 FDA approval of ZORYVE cream
Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com
Investors
Brian Schoelkopf, Head of Investor Relations
ir@arcutis.com
FAQ
What did Arcutis (ARQT) announce on November 17, 2025 about ZORYVE 0.3%?
When is the FDA decision date for Arcutis' ZORYVE (ARQT) pediatric sNDA?
Would ZORYVE 0.3% be the first topical PDE4 for young children if approved (ARQT)?
What clinical data support Arcutis' sNDA for ZORYVE 0.3% in ages 2–5 (ARQT)?
What is ZORYVE 0.3% currently approved for before this sNDA (ARQT)?
How should investors view the sNDA acceptance for ARQT ahead of the June 29, 2026 date?
