U.S. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis 

Rhea-AI Summary

Arcutis Biotherapeutics (ARQT) announced FDA's acceptance of a supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2-5 years. The FDA set a PDUFA target date of October 13, 2025.

The application is supported by positive results from the INTEGUMENT-PED Phase 3 trial of 652 children. Key findings showed that 25.4% of ZORYVE-treated children achieved vIGA-AD Success at Week 4, compared to 10.7% for vehicle control (P<0.0001). The treatment demonstrated rapid itch reduction, with over one-third of children achieving a four-point reduction in WI-NRS at Week 4.

If approved, ZORYVE cream will provide a new treatment option for approximately 1.8 million children aged 2-5 with atopic dermatitis in the United States. The drug showed a favorable safety profile consistent with results in adults and older pediatric subjects.

Positive

• Strong efficacy with 25.4% success rate vs 10.7% for placebo
• Rapid symptom improvement from Week 1
• Large market opportunity of 1.8M potential patients
• Favorable safety profile with low adverse events
• Met all secondary endpoints in Phase 3 trial

Negative

• Long wait for potential approval (October 2025)
• Success rate of 25.4% might be considered modest
• to specific age group (2-5 years)

Insights

Financial Analyst

The FDA's acceptance of Arcutis' sNDA for ZORYVE cream 0.05% for atopic dermatitis in children 2-5 years represents a significant potential revenue catalyst with the October 13, 2025 PDUFA date. This expansion could unlock access to approximately 1.8 million additional patients in the US, substantially enlarging ZORYVE's addressable market.

The strong efficacy data (25.4% success rate vs. 10.7% for vehicle) coupled with favorable safety profile positions ZORYVE advantageously in the pediatric dermatology market, where safety concerns often limit treatment options. The rapid onset of action (improvements as early as Week 1) is particularly valuable for pediatric patients and their caregivers, potentially driving both adoption and adherence.

From a competitive standpoint, ZORYVE would face less intense competition in the 2-5 age group compared to adult and adolescent segments. Current pediatric atopic dermatitis treatments primarily include topical corticosteroids (with safety limitations for long-term use), tacrolimus/pimecrolimus (with boxed warnings), and crisaborole (with efficacy limitations). As a non-steroidal PDE4 inhibitor without the safety concerns of existing options, ZORYVE could capture significant market share in this underserved segment.

Financially, this expansion aligns with Arcutis' strategy to maximize the ZORYVE franchise value across multiple indications and age groups, creating a more diversified revenue base. Pediatric exclusivity provisions could also extend intellectual property protection, enhancing the long-term value proposition. For investors, this development represents a meaningful growth opportunity that could accelerate Arcutis' path to profitability while strengthening its position in the competitive immunodermatology landscape.

Dermatology Expert

The FDA's acceptance of Arcutis' sNDA for ZORYVE cream 0.05% represents a potentially paradigm-shifting advancement in pediatric atopic dermatitis treatment. The 2-5 year age group presents unique therapeutic challenges due to their enhanced skin permeability, heightened susceptibility to side effects, and difficulty with treatment adherence.

The INTEGUMENT-PED trial results are particularly impressive given the study population's disease burden, with a mean BSA of 22% - indicating moderate-to-severe disease in many participants. The significant efficacy demonstrated (25.4% achieving vIGA-AD success vs. 10.7% for vehicle) across this spectrum suggests broad clinical utility.

ZORYVE's mechanism as a PDE4 inhibitor specifically targets the dysregulated inflammatory cascade in atopic dermatitis by inhibiting production of pro-inflammatory cytokines while increasing anti-inflammatory mediators. This targeted approach contrasts with the broader immunosuppression of topical corticosteroids or calcineurin inhibitors.

The rapid itch reduction (over one-third achieving a 4-point WI-NRS reduction by Week 4) addresses the most distressing symptom for children and caregivers. Persistent scratching not only exacerbates skin damage but disrupts sleep and development, creating substantial family burden.

The long-term extension data (up to 52 weeks) is particularly valuable for this chronic, relapsing condition that typically requires ongoing management. The favorable safety profile throughout this extended period addresses a critical unmet need, as current options like topical corticosteroids carry risks of skin atrophy, hypothalamic-pituitary-adrenal axis suppression, and growth impairment with prolonged use.

If approved, ZORYVE would offer dermatologists a non-steroidal, steroid-sparing option that could potentially interrupt the atopic march - the progression from atopic dermatitis to allergic rhinitis and asthma - by providing earlier effective control of skin inflammation and barrier dysfunction.

• U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025 
• Application supported by positive efficacy and safety data from pivotal Phase 3 trial, pivotal long-term extension study, and Phase 1 pharmacokinetic study 
• If approved, ZORYVE cream 0.05% will be a new topical therapy option for approximately 1.8 million children aged 2 to 5 with atopic dermatitis (AD) in the United States

WESTLAKE VILLAGE, Calif., Feb. 26, 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’s acceptance of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old. The FDA has set a PDUFA target action date of October 13, 2025 for this application. 

“In clinical trials, investigational ZORYVE cream 0.05% has shown significant positive results in treating AD in children 2 to 5 years old. The data highlight the efficacy of the cream, along with its favorable safety and tolerability profile, which are critical when prescribing a long-term treatment for children with AD,” said Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC, and INTEGUMENT PED clinical trial investigator. “In children, AD often occurs on sensitive areas like the face and neck. In addition to persistent itching and scratching, AD is associated with a lower quality of life for the affected child and caregiver. If approved, ZORYVE cream 0.05% will provide a new treatment option that offers long-term relief and can help alleviate the disease burden for children and their caregivers.” 

Atopic dermatitis is a chronic, genetically predisposed, relapsing inflammatory skin disease that has unique clinical presentations across the lifespan. The disease may appear as a red, intensely itchy rash that can occur anywhere on the body. It may present differently in infants, children, and adults. 

“Topical treatments prescribed to young AD patients today can have significant shortcomings, which lead to difficult trade-offs between efficacy, safety, and tolerability. Our clinical trials demonstrate that investigational ZORYVE cream 0.05% effectively relieves the itchy rash of AD in these very young children, with a safe and tolerable profile that dermatology clinicians trust from their experience with our ZORYVE portfolio,” said Frank Watanabe, president and CEO of Arcutis. “Our commitment to helping people with immune-mediated dermatological diseases is underscored by our efforts to provide an alternative to steroids with a new targeted topical therapy option with the potential to advance the standard of care for the approximately 1.8 million children between the ages of 2 and 5 living with AD.”

The sNDA is supported by positive results from the pivotal INTEGUMENT-PED Phase 3 trial (4 weeks), the INTEGUMENT-OLE long-term extension study (up to 52 weeks), as well as a Phase 1 pharmacokinetic study.

INTEGUMENT-PED, the pediatric pivotal vehicle-controlled Phase 3 trial, enrolled 652 children from 2 to 5 years of age, with an AD Body Surface Area (BSA) ranging from 3% to 82% and a mean BSA of 22%. Key trial results include:

• The data showed significant improvements as early as Week 1. At Week 4, 25.4% of children treated with ZORYVE cream 0.05% achieved vIGA-AD 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, compared to 10.7% of children treated with vehicle (P<0.0001).
• The study also met all pre-determined secondary endpoints, with significant improvements seen across all time points, including vIGA-AD success and vIGA-AD of ‘Clear’ and ‘Almost Clear’ at Week 1. 
• ZORYVE also helped rapidly reduce the itch, with over a third of the children who had a baseline Worst Itch Numeric Scale (WI-NRS) score ≥4 (as reported by the caregiver) achieving a four-point reduction in WI-NRS at Week 4 (vs. 18.0% for vehicle-treated children [nominal P=0.0002]). 
  

ZORYVE cream 0.05% was well-tolerated in the studies. Overall, the incidence of adverse events (AEs) in INTEGUMENT-PED was low. The safety profile observed in 2- to 5-year-old pediatric subjects treated with ZORYVE cream 0.05% during the trial was consistent with the favorable safety profile established in adults and older pediatric subjects treated with ZORYVE cream 0.15% with mild to moderate AD.

About ZORYVE (roflumilast) Cream 
Roflumilast cream is a next generation 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. Roflumilast cream 0.3% (ZORYVE^®) is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. Roflumilast cream 0.15% (ZORYVE^®) is approved by the FDA for the topical treatment of mild to moderate AD in patients 6 years of age and older. ​​In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Eczema Product.” 

INDICATIONS 
ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

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 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). 

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. 

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, AD, 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 FDA approval of ZORYVE cream 0.05%, the potential of real-world use results of ZORYVE cream in AD in children aged 2 to 5, and the potential for ZORYVE cream to advance the standard of care in AD 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 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. 

Contacts: 
Media 
Amanda Sheldon, Head of Corporate Communications 
media@arcutis.com 

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

FAQ

What are the success rates of ZORYVE cream 0.05% in treating atopic dermatitis in children aged 2-5?

In the INTEGUMENT-PED Phase 3 trial, 25.4% of children treated with ZORYVE achieved vIGA-AD Success at Week 4, compared to 10.7% with vehicle control.

When is the FDA PDUFA date for ARQT's ZORYVE cream 0.05% pediatric atopic dermatitis application?

The FDA has set a PDUFA target action date of October 13, 2025.

How many children could potentially benefit from ARQT's ZORYVE cream treatment?

Approximately 1.8 million children aged 2-5 with atopic dermatitis in the United States could benefit from this treatment.

What were the safety results for ARQT's ZORYVE cream in the INTEGUMENT-PED trial?

The treatment showed a favorable safety profile with low incidence of adverse events, consistent with results in adults and older pediatric subjects.

How quickly did ARQT's ZORYVE show improvement in atopic dermatitis symptoms?

Significant improvements were observed as early as Week 1, with over one-third of children achieving significant itch reduction by Week 4.