FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months

Rhea-AI Summary

Arcutis Biotherapeutics (Nasdaq: ARQT) reported FDA acceptance of a supplemental New Drug Application for ZORYVE (roflumilast) cream 0.05% to treat mild to moderate atopic dermatitis in infants aged 3–24 months. The FDA set a PDUFA target action date of February 23, 2027.

The sNDA is backed by Phase 2 INTEGUMENT-INFANT and Phase 1 PK data in 3–24 month-olds, showing safety and efficacy over 4 weeks. ZORYVE 0.05% is once-daily, steroid-free and already approved for children aged 2–5 years.

Positive

• FDA accepts sNDA for ZORYVE 0.05% in infants 3–24 months, PDUFA February 23, 2027
• 34.4% of infants achieved vIGA-AD success after 4 weeks of ZORYVE 0.05% treatment
• 58.3% of infants reached EASI-75 at Week 4; 34% achieved EASI-75 at Week 2
• 67.5% vIGA-scalp success at Week 4 among infants with baseline scalp involvement
• 46.6% of infants had ≥25% pruritus improvement within 10 minutes after application (DPS-25)
• ZORYVE 0.05% showed a well-tolerated safety profile with no new safety signals over 4 weeks

Negative

• Most frequently reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting in infant studies

Argus Jul 8 session 1 alert

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Details

Market move: ARQT +3.00% in the Jul 8 session. sNDA acceptance for infant AD

$3.26B Mkt Cap at Peak Alert

On Jul 8, the day this news came out, ARQT closed 3.00% above the previous close.

Data tracked by StockTitan Argus for the Jul 8 session.

Key Figures

PDUFA date: February 23, 2027 INTEGUMENT-INFANT enrollment: 101 infants Phase 1 enrollment: 19 infants +5 more

PDUFA date

February 23, 2027

FDA target action date for ZORYVE 0.05% infant sNDA

INTEGUMENT-INFANT enrollment

101 infants

Phase 2 open-label study, 3 to <24 months, 4 weeks

Phase 1 enrollment

19 infants

Open-label PK study in mild to moderate atopic dermatitis

vIGA-AD success

34.4%

Week 4, n=96 completers in INTEGUMENT-INFANT

EASI-75 Week 4

58.3%

Reduction from baseline in EASI score at Week 4

EASI-75 Week 2

34%

Reduction from baseline in EASI score at Week 2

vIGA-scalp success

67.5% (27/40)

Infants with at least mild scalp involvement at Week 4

Rapid itch improvement

46.6%

≥25% pruritus improvement within 10 minutes (DPS-25), n=88

Previous Clinical trial Reports

5 past events · Latest: Apr 27

Same Type 5 events

1. Apr 27

   sNDA submission

   24h Move

   +0.7%

   Filed sNDA to extend ZORYVE 0.05% atopic dermatitis label to infants.

2. Mar 18

   conference data preview

   24h Move

   -2.1%

   Planned AAD presentations of new clinical and caregiver-reported ZORYVE data.

3. Feb 02

   topline trial results

   24h Move

   +0.8%

   Reported positive INTEGUMENT-INFANT Phase 2 topline results in mild–moderate atopic dermatitis.

4. Nov 17

   sNDA acceptance

   24h Move

   +4.7%

   FDA accepted sNDA for ZORYVE 0.3% plaque psoriasis in children 2–5.

5. Nov 13

   trial enrollment complete

   24h Move

   -2.5%

   Completed enrollment for INTEGUMENT-INFANT Phase 2 atopic dermatitis study.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pdufa, supplemental new drug application, pharmacokinetic, eczema area and severity index, +2 more

6 terms

pdufa regulatory

"FDA has set a Prescription Drug User Fee Act (PDUFA) target action date"

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

supplemental new drug application regulatory

"has accepted its supplemental New Drug Application (sNDA) for ZORYVE"

A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.

pharmacokinetic medical

"Phase 1 open-label pharmacokinetic (PK) study"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

eczema area and severity index medical

"reduction from baseline in Eczema Area and Severity Index (EASI-75)"

A standardized clinical score that measures how much skin is affected by eczema and how severe the lesions are, combining area and intensity into one number much like a report card for a skin condition. Investors care because changes in this score are often used as a primary measure of a treatment’s effectiveness in clinical trials, influencing regulatory approval chances, market potential, and the perceived value of companies developing eczema therapies.

validated investigator global assessment for atopic dermatitis medical

"achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success"

A validated Investigator Global Assessment for atopic dermatitis is a clinician-rated scale that gives a single, standardized score for how severe a patient’s eczema is at a given time. It matters to investors because it is a common, accepted trial endpoint used to show whether a treatment works; clear improvements on this scale can drive regulatory approvals, label claims and market uptake, much like a referee’s overall score confirming a team’s performance.

dynamic pruritus scale medical

"based on the Dynamic Pruritus Scale (DPS-25) (n=88)."

A dynamic pruritus scale is a measurement tool that tracks how an individual’s itch intensity rises and falls over time, often using repeated patient ratings or sensors to capture moment-to-moment changes rather than a single snapshot. Investors care because it can serve as a clinical trial endpoint or regulatory evidence that a treatment meaningfully reduces uncomfortable fluctuations; think of it like a weather app for symptoms that shows whether a therapy clears up storms or only dulls a breeze.

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Add on Google Not now

• FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027
• Application supported by positive results from Phase 2 open-label INTEGUMENT-INFANT study and Phase 1 open-label pharmacokinetic (PK) study
• 1 million children under the age of 2 are treated topically for atopic dermatitis in the United States, representing 10% of all adults and children treated topically for atopic dermatitis
  
  

WESTLAKE VILLAGE, Calif., July 08, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months. The FDA has set a PDUFA target action date of February 23, 2027.

“Infants with atopic dermatitis are particularly vulnerable to burdensome symptoms such as intense itch and sleep disruption, which can impact the whole family. Managing these symptoms can be particularly challenging for parents and caregivers due to the very limited FDA-approved treatment options as well as concerns about the use of topical steroids on infants whose skin barrier and immune system are still developing,” said Lawrence F. Eichenfield, MD, of Rady Children’s Hospital San Diego and the University of California San Diego School of Medicine and an INTEGUMENT-INFANT clinical trial investigator. “There is a significant unmet need in this population for therapies that can be used anywhere on the body for any duration of time, including on sensitive areas such as the face and skin folds. If approved, ZORYVE cream 0.05% could provide clinicians and caregivers with an important new steroid-free treatment option that was specifically developed for infants and very young children.”

Atopic dermatitis is the most common form of eczema and often begins during infancy, contributing to significant burden for both infants and caregivers due to the chronic cycling of itching and scratching that can lead to discomfort and disruptions in sleep.

“This sNDA acceptance underscores the gap in approved treatments for very young children with atopic dermatitis,” said Frank Watanabe, president and CEO of Arcutis. “If approved, investigational ZORYVE cream 0.05% would be the first once-daily advanced targeted topical treatment for this especially vulnerable patient population and would provide a much-needed non-steroidal treatment option that effectively reduces symptoms of atopic dermatitis like itch quickly, and with a safe and well-tolerated profile. This expanded indication would further reinforce ZORYVE’s potential to serve as a foundational treatment option for individuals with atopic dermatitis from infancy through adulthood.”

The sNDA is supported by positive results from the Phase 2 open-label INTEGUMENT-INFANT study, as well as a Phase 1 open-label pharmacokinetic (PK) study, both of which evaluated once-daily ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The INTEGUMENT-INFANT study enrolled 101 infants and assessed safety, tolerability, and exploratory efficacy over 4 weeks. The Phase 1 study enrolled 19 infants. Both studies demonstrated PK, safety, and efficacy profiles over 4 weeks that were consistent with those from prior atopic dermatitis studies in children 2 to 5 years of age treated with ZORYVE cream 0.05%.

Key trial results include:

• ZORYVE cream 0.05% showed a well-tolerated, safe profile consistent with previous studies, with no new safety signals identified through 4 weeks of treatment. The most frequently reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting.
• ZORYVE cream 0.05% demonstrated rapid disease clearance through 4 weeks of treatment.
  • Among infants who completed 4 weeks of treatment in INTEGUMENT-INFANT (n=96), 34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success, defined as a score of 0 (Clear) or 1 (Almost Clear) with a ≥2-grade improvement from baseline.
  • 58.3% of infants achieved at least a 75% reduction from baseline in Eczema Area and Severity Index (EASI-75) at Week 4, with 34% achieving EASI-75 at Week 2.
  • Among infants with at least mild scalp involvement at baseline, 67.5% (27/40) achieved vIGA-scalp success at Week 4.
• Caregivers also reported rapid improvements in itch, with 46.6% of infants achieving at least a 25% improvement from baseline in pruritus within 10 minutes after application, as assessed by caregivers, based on the Dynamic Pruritus Scale (DPS-25) (n=88).

ZORYVE cream 0.05% is a once-daily, steroid-free, non-greasy topical treatment that does not contain sensitizing excipients or irritants such as propylene glycol, polyethylene glycol, ethanol, or fragrances. ZORYVE cream 0.05% is already approved for the treatment of mild to moderate atopic dermatitis in children aged 2-5 years.

About Atopic Dermatitis
Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. Atopic dermatitis is a chronic, relapsing, and genetically predisposed inflammatory skin disease. The disease typically appears as a red, intensely itchy rash that can occur anywhere on the body. Younger children may have especially widespread atopic dermatitis, including on the face and neck.

Atopic dermatitis is often initially diagnosed during childhood with approximately 90% of people with atopic dermatitis developing symptoms by age 5 and up to 60% of children developing symptoms within their first year. Pediatric atopic dermatitis can negatively impact the entire family by significantly disrupting sleep, increasing the risk of skin infections, and leading to developmental and emotional strain for both the child and caregivers.

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 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 0.3% and ZORYVE foam 0.3% were also awarded the National Psoriasis Foundation’s Seal of Recognition — the first FDA-approved prescription brand to receive the honor. Additionally, the American Academy of Dermatology (AAD) issued a strong recommendation for the use of ZORYVE cream 0.15% in adults with mild to moderate atopic dermatitis, as well as a strong recommendation for the use of ZORYVE cream 0.05% for children aged 2-5 years and ZORYVE cream 0.15% for children aged 6 years and older with mild to moderate atopic dermatitis. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Best Eczema Product.”

INDICATIONS
ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.

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.

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

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 reported (≥1%) for ZORYVE cream 0.05% for pediatric patients with atopic dermatitis 2 to 5 years of age were upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients with atopic dermatitis 6 years of age or older were headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were 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 reported (≥1%) for ZORYVE foam 0.3% for plaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream.

ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company delivering meaningful innovation to address the needs of individuals living with chronic inflammatory skin diseases. Over the past decade, Arcutis has successfully developed a robust portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases, driven by a commitment to solving the most persistent patient challenges in dermatology. Arcutis’ unique dermatology development platform, built on established scientific pathways and coupled with deep clinical dermatology and commercial expertise, enables us to efficiently develop, scale, and deliver our differentiated therapies while advancing a growing pipeline across a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.

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 0.05%, and the potential for ZORYVE cream and ZORYVE foam to advance the standard of care in AD, plaque psoriasis 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, 2026, 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
Brian Schoelkopf, Head of Investor Relations
ir@arcutis.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Arcutis (NASDAQ: ARQT) announce about FDA review of ZORYVE cream 0.05% for infants with atopic dermatitis?

Arcutis announced FDA acceptance of a supplemental New Drug Application for ZORYVE cream 0.05% to treat mild to moderate atopic dermatitis in infants aged 3–24 months. According to Arcutis, this expands the proposed indication beyond currently approved use in children aged 2–5 years.

What is the PDUFA date for the Arcutis (ARQT) ZORYVE 0.05% sNDA in infant atopic dermatitis?

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027 for the ZORYVE 0.05% sNDA. According to Arcutis, this date marks when the FDA is expected to complete its review of the proposed infant indication.

What were the key INTEGUMENT-INFANT Phase 2 results for ZORYVE cream 0.05% in infants with atopic dermatitis?

In INTEGUMENT-INFANT, 34.4% of infants completing 4 weeks achieved vIGA-AD success with ZORYVE 0.05%. According to Arcutis, 58.3% reached EASI-75 at Week 4, and safety, tolerability, and pharmacokinetics over 4 weeks were consistent with prior studies in children aged 2–5 years.

How effective was ZORYVE cream 0.05% at reducing itch in infants with atopic dermatitis?

ZORYVE cream 0.05% produced rapid itch improvement in infants with atopic dermatitis. According to Arcutis, 46.6% of infants achieved at least a 25% improvement from baseline pruritus within 10 minutes after application, based on caregiver assessments using the Dynamic Pruritus Scale (DPS-25).

What scalp clearance outcomes were reported for ZORYVE 0.05% in infants with atopic dermatitis?

Among infants with at least mild scalp involvement at baseline, 67.5% achieved vIGA-scalp success at Week 4 when treated with ZORYVE 0.05%. According to Arcutis, this scalp response was observed within the 4-week INTEGUMENT-INFANT Phase 2 open-label study of once-daily therapy.

For which age groups is ZORYVE cream 0.05% currently approved to treat atopic dermatitis?

ZORYVE cream 0.05% is already approved for treating mild to moderate atopic dermatitis in children aged 2–5 years. According to Arcutis, the new sNDA seeks to expand use to infants aged 3–24 months, subject to FDA review and decision by February 23, 2027.

How many young children in the US are treated topically for atopic dermatitis, and why is Arcutis targeting infants?

About 1 million children under age 2 in the US receive topical treatment for atopic dermatitis, representing 10% of all topically treated patients. According to Arcutis, limited FDA-approved options and steroid concerns in infants highlight the rationale for pursuing ZORYVE 0.05% in this population.