TORONTO, ON, January 21, 2025 — Arcutis Canada, Inc., a commercial-stage company focused on delivering meaningful innovations in immuno-dermatology, is pleased to announce that Health Canada has accepted for review the Supplement to a New Drug Submission (SNDS) for roflumilast foam 0.3%. This steroid-free, once-daily phosphodiesterase-4 (PDE4) inhibitor is being reviewed for the topical treatment of scalp and body psoriasis in patients aged 12 years and older.

Psoriasis is a chronic immune-mediated condition that affects approximately 2% to 3% of Canadians.¹ Scalp psoriasis, a common manifestation of plaque psoriasis, presents unique treatment challenges due to the presence of hair, which can complicate the application of topical therapies. Nearly half of individuals with plaque psoriasis experience scalp involvement, often accompanied by plaques on other parts of the body.¹

Roflumilast foam, if approved, would offer a steroid-free, easily applied option that addresses the unique needs of scalp and body psoriasis, providing a novel option for individuals whose symptoms may require an alternative approach to traditional treatments.

The SNDS is supported by data from Arcutis’ pivotal ARRECTOR (A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis) Phase 3 trial, a Phase 2b study, and long-term efficacy and safety data generated from the ZORYVE^® cream development program in plaque psoriasis.

Key findings from the ARRECTOR trial include:

About Topical Roflumilast
Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective PDE4 inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. 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 approved in Canada for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Health Canada has authorized the use of roflumilast foam 0.3% (ZORYVE) for the treatment of seborrheic dermatitis in patients 9 years of age and older.

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

Roflumilast cream 0.15% is under review by Health Canada for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older, supported by clinical results from Arcutis’ Phase 2 and pivotal Phase 3 trials in AD.

About Arcutis

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

Forward-Looking Statements

Arcutis cautions you that statements contained in this media alert 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 for approval and availability of roflumilast foam in Canada for the treatment of scalp and body psoriasis in adults and adolescents, the potential for roflumilast foam to enhance available options for scalp and body psoriasis,  the potential treatment results from real world clinical practice, the potential to use roflumilast foam over a long period of time, or chronically, and the potential for roflumilast foam to advance the standard of care in scalp and body 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 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
media@arcutis.com

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

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