The U.S. Food and Drug Administration has approved Arcutis Biotherapeutics’ supplemental New Drug Application to expand the indication for ZORYVE® (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children as young as 2 years old.

ZORYVE cream 0.3% is a once-daily, steroid-free topical therapy that is safe, effective, and well tolerated. According to Arcutis, it is suitable for use anywhere on the body and has no limitations on duration of use. This approval marks the seventh FDA approval for ZORYVE in four years and expands a treatment option for young children living with plaque psoriasis.

Key Highlights

ZORYVE cream 0.3% is the first once-daily, non-steroidal therapy approved for children with plaque psoriasis as young as 2 years of age.

The treatment is approved for plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older.

The cream is designed for use anywhere on the body, including sensitive areas such as the face and skin folds.

The approval was supported by a 4-week Maximal Usage Systemic Exposure study and long-term safety data from an open-label extension study.

This milestone represents the seventh FDA approval for ZORYVE in four years.

Addressing a Treatment Gap in Pediatric Plaque Psoriasis

Plaque psoriasis is a chronic, immune-mediated inflammatory skin disease that can begin early in life and persist for decades. It can appear as raised, red, or discolored plaques covered with silvery scales. Symptoms may include itching, scaling, redness, and flaking. On darker skin tones, plaques may appear more grayish, purplish, or brown.

For young children, plaque psoriasis can be especially challenging when it affects sensitive skin areas, including the face, genitals, and intertriginous areas, where skin touches skin. These areas may include the armpits, under the breasts, stomach folds, between the buttocks, and the groin area.

Topical corticosteroids are commonly used in the management of pediatric plaque psoriasis, but they are not always recommended for long-term continuous use or for certain sensitive areas. This approval gives clinicians and caregivers another option to consider when managing a chronic condition in young children.

“Young children with plaque psoriasis face unique challenges, including disease involvement on sensitive skin, such as the face and skin folds,” said Lisa Swanson, MD, FAAD, board-certified pediatric dermatologist and clinical trial investigator at Ada West Dermatology, in the Arcutis announcement. She noted that the approval provides physicians and caregivers with a targeted topical therapy that can be used anywhere on the body for any duration of time.

Clinical Data Supporting the Expanded Approval

The expanded approval was based on data from a 4-week Maximal Usage Systemic Exposure study, ARQ-151-216, which evaluated ZORYVE cream 0.3% in children ages 2 to 5 years with plaque psoriasis. The open-label study assessed pharmacokinetics, safety, tolerability, and exploratory efficacy in children with plaque psoriasis involving at least 2% body surface area.

Supportive long-term safety data came from an open-label extension study, ARQ-151-306, which evaluated the long-term safety, tolerability, and efficacy of ZORYVE cream 0.3% in individuals ages 2 to 5 years with plaque psoriasis for up to 24 weeks of treatment. According to Arcutis, results demonstrated safety and efficacy profiles that were generally consistent with those observed in the DERMIS-1 and DERMIS-2 pivotal Phase 3 trials in adolescents and adults.

A Once-Daily, Steroid-Free Topical Option

ZORYVE cream 0.3% is a topical formulation of roflumilast, an advanced targeted phosphodiesterase type 4 inhibitor. PDE4 is an intracellular enzyme and an established target in dermatology. Inhibiting PDE4 decreases the production of pro-inflammatory mediators, helping reduce inflammation in the skin and support immune balance.

The newly expanded indication may be especially meaningful for families and clinicians seeking a steroid-free option that can be used as part of longer-term care planning. Arcutis stated that ZORYVE cream 0.3% is suitable for use anywhere on the body with no restrictions on duration of use.

Leah Howard, president and chief executive officer of the National Psoriasis Foundation, described the approval as an important advancement for a population that has had limited treatment options. She noted that young children with plaque psoriasis and their caregivers have faced a significant treatment gap for years.

Access and Availability

According to Arcutis, ZORYVE cream is widely available through key wholesaler and dermatology pharmacy channels. The company also offers the ZORYVE® Direct Program, which supports prescribed patients by helping navigate the insurance process, assisting with adherence, and providing access to a savings card program for eligible commercially insured patients. Arcutis also offers Arcutis Cares™, a patient assistance program that provides ZORYVE at no cost to financially eligible patients who are uninsured or underinsured.

Patients and caregivers should speak with a qualified healthcare professional to determine whether ZORYVE cream 0.3% is appropriate for their child.

Indication

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

Important Safety Information

ZORYVE is contraindicated in patients with moderate to severe liver impairment, also known as Child-Pugh B or C.

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

The most common adverse reactions reported in at least 1% of patients using ZORYVE cream 0.3% for plaque psoriasis were diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection.

Patients and caregivers should review the full prescribing information and consult a healthcare provider for complete safety details.

About Plaque Psoriasis

Psoriasis is a common, chronic inflammatory skin disease that affects nearly 9 million people in the United States. It may appear anywhere on the body, including the knees, elbows, torso, face, genitals, and intertriginous areas. Symptoms may include itch, scaling, redness, and flaking.

About ZORYVE®

ZORYVE is a topical formulation of roflumilast and is part of Arcutis’ portfolio of targeted topical therapies for inflammatory dermatologic conditions. ZORYVE is approved in different formulations and strengths for plaque psoriasis, seborrheic dermatitis, and atopic dermatitis in specified adult and pediatric populations.

About Arcutis

Arcutis Biotherapeutics, Inc. is a commercial-stage medical dermatology company focused on developing meaningful innovations for individuals living with chronic inflammatory skin diseases. The company’s dermatology development platform is built on established scientific pathways, clinical dermatology expertise, and commercial experience across inflammatory dermatologic conditions.

For more information about ZORYVE, including full prescribing information, patients and clinicians can visit the official ZORYVE website or speak with a healthcare professional.

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 real-world use results of ZORYVE® cream 0.3%, and the potential for ZORYVE cream to advance the standard of care in plaque psoriasis, including this young patient population.

These statements are subject to substantial known and unknown risks, uncertainties, and other factors that may cause the Company’s 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 actual results to differ include risks inherent in the Company’s business, reimbursement and access to its products, the impact of competition, and other important factors discussed in the “Risk Factors” section of the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission 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, the Company undertakes 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