FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age
Arcutis Biotherapeutics announced that the FDA approved ZORYVE (roflumilast) cream 0.15% for treating mild to moderate atopic dermatitis (AD) in patients aged six and older.
ZORYVE, a steroid-free cream, reduces itch and provides rapid disease clearance, showing efficacy and safety in up to 56 weeks of treatment.
Clinical trials demonstrated significant improvements, with 69% of patients showing at least a 50% reduction in symptoms within four weeks.
This marks Arcutis' third FDA approval in two years, with the product available by the end of July.
- FDA approval of ZORYVE cream 0.15% for atopic dermatitis in patients aged 6 and older.
- ZORYVE provides rapid and significant itch reduction.
- Clinical trials showed 69% of patients had a 50% improvement in symptoms in 4 weeks.
- Low incidence of Treatment Emergent Adverse Events (TEAEs).
- Expected market launch by the end of July.
- None.
Arcutis Biotherapeutics Inc. (Nasdaq: ARQT) securing FDA approval for ZORYVE® (roflumilast) cream for treating mild to moderate atopic dermatitis (AD) in both adults and children is a significant milestone financially. This is the company's third FDA approval in two years, reflecting a robust pipeline and strong R&D capabilities.
Revenue potential: With approximately
Competitive positioning: ZORYVE's unique selling proposition is its steroid-free formulation, addressing concerns over long-term steroid use. This differentiation could enable Arcutis to capture market share from existing AD treatments, especially among patients seeking alternatives to steroids.
Short-term vs. long-term impact: In the short term, the stock may experience a positive reaction owing to market enthusiasm about the approval. Long-term, sustained success will depend on commercial execution, payer acceptance and patient adoption.
From a clinical perspective, the approval of ZORYVE® cream for atopic dermatitis (AD) represents a meaningful advancement in dermatology. The cream's efficacy in rapid itch reduction and long-term disease control is noteworthy. Clinical trials demonstrated significant improvements within four weeks, with some patients experiencing relief within 24 hours. This swift action can dramatically improve the quality of life for AD patients, who often suffer from persistent and disruptive itching.
Mechanism of action: ZORYVE operates as a phosphodiesterase 4 (PDE4) inhibitor, acting directly on itch-signaling nerves and inflammatory pathways. This mechanism provides a targeted approach to managing AD symptoms without the systemic side effects associated with steroids.
While the cream was well-tolerated with a low incidence of adverse events, it remains critical for patients and healthcare providers to monitor for potential side effects. The reassuring safety profile in both short-term and long-term studies supports its use as a viable treatment option for both adults and children.
The inclusion of ZORYVE® cream in Arcutis’ product portfolio significantly strengthens the company's market position in the dermatology sector. AD, being the most common type of eczema in the United States, represents a lucrative and expanding market.
Market dynamics: The AD treatment market has traditionally been dominated by topical steroids, which have associated long-term use risks. ZORYVE's non-steroidal nature could attract a substantial number of patients and caregivers looking for safer alternatives, potentially driving high adoption rates.
Commercial strategy: Arcutis' strategy to ensure wide availability through key pharmacy channels and patient support programs, like the ZORYVE Direct Program, is strategically sound. This approach not only facilitates access but also addresses potential cost barriers, enhancing patient adherence and satisfaction.
Overall, ZORYVE's approval and upcoming market launch are poised to positively influence Arcutis' market presence and growth trajectory in the dermatology space.
- ZORYVE cream provides rapid relief, with efficacy, safety, and tolerability demonstrated up to 56 weeks of treatment
- ZORYVE cream rapidly and significantly reduces itch, the most bothersome symptom of atopic dermatitis (AD)
- Once-daily cream is for use anywhere on the body for any duration
- AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States
- Third FDA approval for Company in two years
- Commercial product expected to be available by the end of July
WESTLAKE VILLAGE, Calif., July 09, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE (roflumilast) cream,
“The chronic nature of AD coupled with the disease instability often leaves patients and caregivers feeling that they are constantly chasing their AD flares,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice chair of the department of dermatology at UC San Diego School of Medicine and INTEGUMENT study investigator. “ZORYVE rapidly improves and controls disease, including itch, the most bothersome reported symptom. In clinical trials, 9 in 10 patients saw some improvement at 4 weeks, with
“Living with AD, a chronic inflammatory skin disease, and the intense itching associated with it, can have a profound impact on quality of life and family dynamics for both adults and children,” said Wendy Smith Begolka, chief strategy officer at the National Eczema Association. “We are pleased to see new advancements and innovation in treatment for the millions of children and adults who are suffering with this serious skin disease.”
AD is the most common form of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. Itching (pruritus) is the most burdensome symptom and is the result of skin barrier dysfunction and neuroimmune dysregulation. In clinical trials, ZORYVE cream
“People suffering from AD experience intense itch, rash, and sensitive skin, which warrant effective, safe, and well-tolerated treatments,” said Jonathan Silverberg, MD, PhD, MPH, professor of dermatology, and the director of clinical research and director of contact dermatitis at The George Washington University School of Medicine and Health Sciences in Washington, D.C. “ZORYVE was developed with the AD patient in mind, to deliver the drug in a moisturizing vehicle that is formulated without common sensitizers or irritants and does not further disrupt the abnormal skin barrier. It’s also important to note that in clinical trials ZORYVE monotherapy provided safe and effective long-term disease control to AD patients.”
“Today marks the third FDA approval of a commercial product for Arcutis in just the last two years, and we are thrilled to be able to offer ZORYVE cream
Arcutis intends to make ZORYVE cream
Clinical Data
The sNDA is supported by positive results from three Phase 3 studies, as well as a Phase 2 dose-ranging study, and two Phase 1 pharmacokinetic studies. INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) were two identical Phase 3, parallel group, double-blind, vehicle-controlled trials evaluating the safety and efficacy of ZORYVE cream
The INTEGUMENT-1 and -2 studies each met their primary endpoint of IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of Clear or Almost Clear plus a 2-grade improvement from baseline at Week 4 (INTEGUMENT-1:
Rapid and significant improvement in itch was observed in individuals treated with ZORYVE cream within 24 hours of the first application, as measured by the change from baseline in daily Worst Itch-Numeric Rating Scale (WI-NRS) scores and compared with vehicle (nominal P<0.05). In addition, over
In addition, more than
ZORYVE cream
The INTEGUMENT-OLE open-label study enrolled 658 participants who rolled over from INTEGUMENT-1 or -2. At any time after 4 weeks, INTEGUMENT-OLE participants who achieved a vIGA-AD score of Clear (0) with once-daily application switched to twice-weekly application (130 participants;
A Media Snippet accompanying this announcement is available by clicking on this link.
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 cream and full Prescribing Information for ZORYVE foam.
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
† Subject to eligibility criteria and maximum program limitation. This offer is not valid for patients without commercial drug insurance or whose prescription claims are eligible to be reimbursed, in whole or in part, by any government program.
‡ Subject to financial eligibility requirements. Other terms and restrictions apply.
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