PrZORYVE® Cream 0.05% Receives Health Canada Approval for Children Aged 2 to 5 Years with Mild to Moderate Atopic Dermatitis

• Health Canada approval of new 0.05% cream formulation expands the ZORYVE portfolio to include a once-daily, steroid-free option for younger children
• The 0.05% formulation was specifically selected for young children, with clinical studies demonstrating significant improvements in disease severity as early as Week 1
• Long-term extension study demonstrated a consistent safety profile through 56 weeks

TORONTO, Aug. 20, 2026 /CNW/ -- Arcutis Canada, Inc., a commercial stage company focused on delivering meaningful innovations in immuno-dermatology, today announced that Health Canada has approved ^PrZORYVE^® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis (AD) in pediatric patients 2 to 5 years of age.

Although atopic dermatitis can affect people of all ages, it most often begins during early childhood. With this approval, ZORYVE cream 0.05% expands treatment options for preschool-aged children living with mild to moderate atopic dermatitis, offering a formulation purposefully selected for younger children that combines targeted anti-inflammatory activity with a convenient once-daily, steroid-free treatment.

"Managing atopic dermatitis in young children is about more than controlling disease flares -- it's about finding treatments that prescribers and families can feel comfortable using over the long term. The approval of ZORYVE cream 0.05% for children aged 2 to 5 years expands our ability to treat this chronic inflammatory skin disease with a targeted, corticosteroid-free therapy that is well-suited for use on all affected areas of the body," said dermatologist Dr. Vimal H. Prajapati, Clinical Associate Professor at the University of Calgary, Co-founder and Co-director of the Skin Health & Wellness Centre, Dermatology Research Institute, Dermphi Centre, and Dermphi Shop, as well as Councilor for the International Eczema Council. "Combined with once-daily dosing and a favourable safety profile, it provides clinicians, pediatric patients, and their caregivers with an important new option that can help control inflammation while supporting long-term disease management."

Addressing an Important Need in Early Childhood Atopic Dermatitis

Atopic dermatitis, the most common form of eczema, is characterized by persistent itching, inflamed skin and recurrent flares that can interfere with sleep, daily activities and quality of life for both children and their families. Younger children often experience more widespread disease, with eczema commonly affecting the face, neck and the areas behind the knees and elbows. In Canada, atopic dermatitis affects an estimated 10 to 15 percent of children. Because symptoms frequently begin before the age of five, there is an ongoing need for treatment options that support the long-term management of this chronic disease.

"For families of young children living with eczema, the impact extends far beyond the visible signs and symptoms. The day-to-day realities of managing eczema can place a significant burden on both children and their caregivers." said Amanda Cresswell-Melville, Executive Director, Eczema Society of Canada. "The approval of new treatments expands options for Canadians living with eczema, and offers hope to patients and caregivers struggling with this chronic condition." 

Health Canada's approval is supported by data from the pivotal Phase 3 INTEGUMENT-PED study, which met its primary and key secondary endpoints, demonstrating significant improvements in overall disease severity, with treatment benefits observed as early as Week 1. In the long-term extension study, ZORYVE cream 0.05% demonstrated a consistent safety profile through 56 weeks, supporting its use in the long-term management of mild to moderate atopic dermatitis.

"This approval marks an important milestone for Arcutis and for young children living with atopic dermatitis in Canada," said Jamie Lewis, vice president and general manager, Arcutis Canada. "The approval of ZORYVE cream 0.05% expands the ZORYVE portfolio to include children as young as two years old with a formulation purposefully developed to meet the unique needs of younger children. This milestone reinforces our commitment to addressing unmet needs in medical dermatology and advancing targeted therapies for people living with inflammatory skin diseases at every stage of life. We are proud to provide healthcare professionals with innovative treatment options that can make a meaningful difference for patients and their families."

Clinical Data Supporting Health Canada Approval

The Health Canada approval of ZORYVE cream 0.05% was supported by data from Arcutis' pivotal Phase 3 INTEGUMENT-PED trial (INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis), a Phase 1 pharmacokinetic study, and the long-term extension study, INTEGUMENT-OLE.

INTEGUMENT-PED was a randomized, double-blind, vehicle-controlled, parallel-group study, that evaluated ZORYVE cream or vehicle once-daily for 4 weeks in 652 children ages 2 to 5 years (n=437 treated with ZORYVE cream, n=215 vehicle). INTEGUMENT-OLE was a Phase 3, multicenter, open-label extension study of the long-term safety of ZORYVE cream 0.15% in adults and children ages 6 years and older with atopic dermatitis and ZORYVE cream 0.05% in children ages 2 to 5 years with atopic dermatitis. A total of 658 children and adults from INTEGUMENT-1 and -2 and 562 children from INTEGUMENT-PED enrolled in the INTEGUMENT-OLE study.

Key findings from the INTEGUMENT-PED trial include:

• Disease clearance: At Week 4, 25.4% of children treated with roflumilast cream 0.05% achieved vIGA-AD Success--defined as a validated Investigator Global Assessment–Atopic Dermatitis (vIGA-AD) score of Clear or Almost Clear with a ≥2-grade improvement from baseline--compared with 10.7% treated with inactive vehicle (p<0.0001). Statistically significant improvements were observed as early as Week 1.
• Disease severity: At Week 4, the key secondary endpoint of EASI-75 (≥75% improvement from baseline) was achieved by 39.4% of children treated with roflumilast cream 0.05% compared with 20.6% treated with vehicle (p<0.0001). Differences between treatment groups were observed as early as Week 1.

In the INTEGUMENT-PED trial, the most common adverse reactions reported (≥1%) included upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%). Discontinuation rates due to adverse events were low and comparable between treatment and vehicle groups.

Results from the long-term INTEGUMENT-OLE extension study demonstrated that ZORYVE cream 0.05% was well tolerated through 56 weeks of treatment, with treatment-emergent adverse events predominantly mild to moderate in severity and a safety profile generally consistent with that observed during the 4-week pivotal trial.

About Topical Roflumilast
Arcutis is developing topical cream and foam formulations of roflumilast, an advanced targeted topical phosphodiesterase type 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 cream 0.3% (^PrZORYVE) is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Roflumilast foam 0.3% (ZORYVE) is approved by Health Canada for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, and for the topical treatment of seborrheic dermatitis in patients 9 years of age and older. Roflumilast cream 0.15% (ZORYVE) is approved by Health Canada for the topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. Roflumilast cream 0.05% (ZORYVE) is approved by Health Canada for the topical treatment of mild to moderate atopic dermatitis in patients 2 to 5 years of age.

Both roflumilast cream and foam formulations are non-greasy, moisturizing, are designed to absorb quickly and spread evenly, have a physiological skin pH, and exclude common sensitizing excipients and irritants, including propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, and fragrances.

For more information about roflumilast cream 0.3%, roflumilast cream 0.15%, roflumilast cream 0.05%, and roflumilast foam 0.3%, including prescribing and safety information, please consult the ZORYVE Canadian product monograph here.

About Arcutis

Arcutis Canada, Inc. is a subsidiary of Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), 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.ca.

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 availability of roflumilast cream 0.05% in Canada for the treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age, the potential for roflumilast cream to enhance available treatment options for mild to moderate atopic dermatitis, the potential treatment results from real-world clinical practice, the potential to use roflumilast cream over a long period of time, or chronically, and the potential for roflumilast cream to advance the standard of care for young children with atopic dermatitis 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.

SOURCE Arcutis Canada Inc.

Contacts: Media: Amanda Sheldon, Head of Corporate Communications, [email protected]; Investors: Brian Schoelkopf, Head of Investor Relations, [email protected]