Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over
Arcutis Biotherapeutics (Nasdaq: ARQT) has submitted a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) foam to the FDA for treating scalp and body psoriasis in adults and adolescents ages 12 and over. The once-daily foam significantly improved both scalp and body psoriasis in Phase 2b and Phase 3 trials, with 67% of participants achieving Scalp-Investigator Global Assessment Success at 8 weeks. The treatment also showed rapid reduction in scalp itch within 24 hours and demonstrated a favorable safety profile.
This submission marks Arcutis' fifth topical roflumilast regulatory submission in the U.S. in less than three years. The company believes ZORYVE foam has great potential for adoption in scalp and body psoriasis, building on its success in seborrheic dermatitis treatment.
Arcutis Biotherapeutics (Nasdaq: ARQT) ha presentato una richiesta supplementare di approvazione per un nuovo farmaco (sNDA) all'FDA per ZORYVE® (roflumilast) schiuma per il trattamento della psoriasi del cuoio capelluto e del corpo negli adulti e negli adolescenti di età pari o superiore a 12 anni. La schiuma, applicata una volta al giorno, ha mostrato un miglioramento significativo sia della psoriasi del cuoio capelluto che del corpo negli studi di Fase 2b e Fase 3, con il 67% dei partecipanti che ha raggiunto il Successo nella Valutazione Globale da parte dell’Investigatore del Cuoio Capelluto dopo 8 settimane. Il trattamento ha anche evidenziato una rapida riduzione del prurito del cuoio capelluto entro 24 ore e ha dimostrato un profilo di sicurezza favorevole.
Questa presentazione rappresenta la quinta domanda di approvazione regolatoria per il roflumilast topico da parte di Arcutis negli Stati Uniti in meno di tre anni. L'azienda ritiene che la schiuma ZORYVE abbia un grande potenziale per l'adozione nella psoriasi del cuoio capelluto e del corpo, facendo leva sul suo successo nel trattamento della dermatite seborroica.
Arcutis Biotherapeutics (Nasdaq: ARQT) ha presentado una solicitud suplementaria de nuevo medicamento (sNDA) a la FDA para ZORYVE® (roflumilast) espuma para el tratamiento de psoriasis en el cuero cabelludo y el cuerpo en adultos y adolescentes de 12 años en adelante. La espuma, que se aplica una vez al día, mejoró significativamente tanto la psoriasis del cuero cabelludo como la del cuerpo en ensayos de Fase 2b y Fase 3, con el 67% de los participantes logrando éxito en la Evaluación Global del Investigador del Cuero Cabelludo a las 8 semanas. El tratamiento también mostró una rápida reducción del picor del cuero cabelludo en 24 horas y demostró un perfil de seguridad favorable.
Esta presentación marca la quinta solicitud regulatoria de roflumilast tópico de Arcutis en EE. UU. en menos de tres años. La empresa cree que la espuma ZORYVE tiene un gran potencial de adopción en la psoriasis del cuero cabelludo y el cuerpo, basándose en su éxito en el tratamiento de la dermatitis seborreica.
아르쿠티스 생체의약품(나스닥: ARQT)은 12세 이상의 성인 및 청소년의 두피 및 신체 건선 치료를 위해 FDA에 ZORYVE® (로플루밀라스트) 폼에 대한 보충 신약 신청(sNDA)을 제출했습니다. 하루 한 번 사용하는 이 폼은 2b 및 3상 시험에서 두피와 신체 건선 모두에서 현저한 개선을 보였으며, 참가자의 67%가 8주 후 두피-연구자의 전반적인 평가 성공을 달성했습니다. 이 치료는 또한 24시간 이내에 두피 가려움증의 빠른 감소를 보여주었고, 안전성 프로필이 우수한 것으로 입증되었습니다.
이번 제출은 아르쿠티스가 3년이 채 안 되는 기간 동안 미국에서 제출한 다섯 번째 로플루밀라스트 국소 규제 제출입니다. 회사는 ZORYVE 폼이 두피 및 신체 건선 치료에 큰 잠재력을 가지고 있다고 생각하며, 지루성 피부염 치료에서의 성공을 바탕으로 하고 있습니다.
Arcutis Biotherapeutics (Nasdaq: ARQT) a soumis une demande supplémentaire de nouveau médicament (sNDA) à la FDA pour ZORYVE® (roflumilast) mousse destinée au traitement de la psoriasis du cuir chevelu et du corps chez les adultes et les adolescents âgés de 12 ans et plus. La mousse, appliquée une fois par jour, a considérablement amélioré le psoriasis du cuir chevelu et du corps lors des essais de Phase 2b et Phase 3, avec 67% des participants atteignant le succès de l'Évaluation Globale par l'Investigateur du Cuir Chevelu après 8 semaines. Le traitement a également montré une réduction rapide des démangeaisons du cuir chevelu en 24 heures et a démontré un profil de sécurité favorable.
Cette soumission marque la cinquième demande d'approbation réglementaire d'Arcutis pour le roflumilast topique aux États-Unis en moins de trois ans. L'entreprise pense que la mousse ZORYVE a un grand potentiel d'adoption dans le psoriasis du cuir chevelu et du corps, s'appuyant sur son succès dans le traitement de la dermatite séborrhéique.
Arcutis Biotherapeutics (Nasdaq: ARQT) hat einen ergänzenden Antrag auf Zulassung eines neuen Arzneimittels (sNDA) bei der FDA für ZORYVE® (Roflumilast) Schaum zur Behandlung von Schuppenflechte auf Kopfhaut und Körper bei Erwachsenen und Jugendlichen ab 12 Jahren eingereicht. Der einmal täglich angewendete Schaum verbesserte in den Phase-2b- und Phase-3-Studien sowohl die Schuppenflechte der Kopfhaut als auch die am Körper signifikant, wobei 67% der Teilnehmer nach 8 Wochen den Erfolg in der Globalen Bewertung durch den Investigateur der Kopfhaut erreichten. Die Behandlung zeigte auch eine schnelle Verringerung des Juckreizes der Kopfhaut innerhalb von 24 Stunden und wies ein günstiges Sicherheitsprofil auf.
Diese Einreichung ist der fünfte regulatorische Antrag für topisches Roflumilast von Arcutis in den USA in weniger als drei Jahren. Das Unternehmen glaubt, dass ZORYVE-Schaum großes Potenzial für die Anwendung bei Schuppenflechte auf Kopfhaut und Körper hat, basierend auf seinem Erfolg bei der Behandlung von seborrhoischer Dermatitis.
- Submission of sNDA for ZORYVE foam to treat scalp and body psoriasis
- 67% of participants achieved Scalp-Investigator Global Assessment Success at 8 weeks
- Rapid reduction in scalp itch observed within 24 hours
- Favorable safety and tolerability profile demonstrated
- Fifth topical roflumilast regulatory submission in less than three years
- None.
- Approximately
40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp - Once-daily ZORYVE foam significantly improved both scalp and body psoriasis in a Phase 2b and a pivotal Phase 3 trial
- Data also show rapid reduction in scalp itch as soon as 24 hours after first application
- ZORYVE foam demonstrated a favorable safety and tolerability profile
WESTLAKE VILLAGE, Calif., July 23, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam
“Nearly half of all individuals with plaque psoriasis have involvement of the scalp. Hair-bearing areas present unique treatment challenges that are not easily addressed with creams or ointments. Individuals with plaque psoriasis need steroid-free treatment options that clear plaques anywhere on the body and relieve burdensome symptoms, such as itch and flaking,” said Melinda Gooderham, MSc, MD, FRCPC, medical director, SKiN Centre for Dermatology, investigator with Probity Medical Research, and clinical trial investigator. “Clinical data show that investigational once-daily ZORYVE foam effectively and reliably cleared both scalp and body psoriasis across all efficacy endpoints compared to vehicle, including
"This important milestone represents our fifth topical roflumilast regulatory submission in the United States in less than three years and brings another innovative treatment to the large population of individuals with scalp and body psoriasis. Based on the rapid adoption of ZORYVE foam in seborrheic dermatitis due to the simplicity of using one treatment anywhere on the body, including hair-bearing areas, we believe there is great potential for its adoption in scalp and body psoriasis, once approved,” said Frank Watanabe, president and chief executive officer of Arcutis. “Our team’s ability to execute our clinical development and commercial strategies reinforces Arcutis’ leadership in medical dermatology and positions the ZORYVE portfolio as a new standard of care for the effective treatment of multiple immune-mediated, chronic skin diseases. I would like to thank the clinical investigators, study coordinators, patients, and caregivers who participated in our clinical trials.”
About the Data
The submission is supported by positive results from Arcutis’ pivotal ARRECTOR Phase 3 trial, a Phase 2b study, and long-term efficacy and safety data generated from the ZORYVE cream development program in plaque psoriasis.
The “A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis” (ARRECTOR) study was a parallel group, double-blind, vehicle-controlled pivotal Phase 3 study of the safety and efficacy of roflumilast foam
Two thirds (
In addition, improvement in body itch as measured by the Worst Itch-Numeric Rating Scale (WI-NRS) was also observed at Week 8, with
Roflumilast foam
About Scalp and Body Psoriasis
Scalp psoriasis is a manifestation of plaque psoriasis and sometimes extends to the forehead, back of the neck, or behind or inside the ears. Plaque psoriasis is characterized by raised, red areas of skin (“plaques”) covered with a silver or white scale. Individuals with scalp psoriasis commonly have plaques on other areas of the body as well. Approximately
About ZORYVE (roflumilast) Foam
Roflumilast foam is a once-daily topical foam formulation of roflumilast, a next generation topical phosphodiesterase-4 (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 foam is uniquely formulated for use anywhere on the body, including hair-bearing areas. ZORYVE is the first and only branded topical therapy for three major inflammatory dermatoses.
Indications
ZORYVE foam,
ZORYVE cream,
ZORYVE cream,
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 roflumilast foam to simplify disease management for the treatment of scalp and body psoriasis; the potential of real-world use results of roflumilast foam, as well as the potential approval of roflumilast foam for scalp and body psoriasis. 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
asheldon@arcutis.com
Investors
Latha Vairavan, Vice President, Finance and Investor Relations
lvairavan@arcutis.com
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