Arcutis to Host ZORYVE® (Roflumilast) Cream 0.15% FDA Approval Call With KOL

Rhea-AI Summary

Arcutis Biotherapeutics (Nasdaq: ARQT) has announced a virtual Key Opinion Leader (KOL) event to discuss the recent FDA approval of ZORYVE® (roflumilast) cream 0.15% for treating mild to moderate atopic dermatitis (AD) in adults and children aged 6 and above. The event, scheduled for July 29, 2024, at 8:30am ET, will feature a leading dermatology expert who will address the unmet needs and current treatment landscape for AD. The discussion will highlight ZORYVE's differentiating features and Arcutis' commercialization plans for this newly approved treatment. This event marks a significant milestone for Arcutis in the immuno-dermatology field, potentially impacting their market position and future revenue streams.

Positive

• FDA approval of ZORYVE® cream 0.15% for atopic dermatitis treatment
• Expanded patient base including adults and children down to age 6
• Potential for increased market share in the atopic dermatitis treatment sector

Negative

• None.

WESTLAKE VILLAGE, Calif., July 22, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will host a virtual Key Opinion Leader (KOL) event featuring a leading dermatology and immune-mediated skin disease expert to discuss the unmet need and current treatment landscape for individuals with mild to moderate atopic dermatitis (AD). The event will highlight the differentiating features of and commercialization plans for ZORYVE^® (roflumilast) cream 0.15%, which recently received FDA approval for the treatment of AD in adults and children down to age 6.

Details for the event are as follows:

Monday, July 29, 2024
8:30am ET
To register, click here.

Additional information may be accessed at the “Events” section of the Company’s website.

About Atopic Dermatitis
AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States.

AD is a chronic, relapsing inflammatory skin disease that is genetically pre-disposed and presents across the lifespan. The disease appears as a red, intensely itchy rash that can occur anywhere on the body and may present differently in children and adults. AD presentation can rapidly fluctuate and vary based on geographic location and environment.

About ZORYVE^®
ZORYVE is a steroid-free topical PDE4 inhibitor approved to treat AD, seborrheic dermatitis, and plaque psoriasis. 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.

ZORYVE (roflumilast) cream 0.15% is approved by the FDA for the treatment of mild to moderate atopic dermatitis in individuals 6 years of age and older and ZORVYE cream 0.3% for the topical treatment of plaque psoriasis in individuals 6 years of age and older. Another formulation, ZORYVE foam 0.3%, is available for the treatment of seborrheic dermatitis in adults and children ages 9 and older.

Roflumilast cream for AD is currently being evaluated at a lower dose of 0.05% for children aged 2 to 5 years. In addition, Arcutis has completed its clinical development program for ZORYVE foam 0.3% for the treatment of scalp and body psoriasis and intends to submit an sNDA in the third quarter of 2024.

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.

ZORYVE 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 (≥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%).

The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include 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.

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, atopic dermatitis, 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 of real-world use results of roflumilast cream in AD, the potential for roflumilast cream to advance the standard of care in AD and other inflammatory dermatological conditions, and the Company’s expected timing and plan to commercially launch ZORYVE cream 0.15% by the end of July. 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, and 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 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
asheldon@arcutis.com

Investors
Latha Vairavan, Vice President, Finance and Investor Relations
lvairavan@arcutis.com

FAQ

What is the newly FDA-approved treatment by Arcutis (ARQT) for atopic dermatitis?

Arcutis Biotherapeutics (ARQT) recently received FDA approval for ZORYVE® (roflumilast) cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children aged 6 and above.

When is Arcutis (ARQT) hosting the KOL event to discuss ZORYVE® cream approval?

Arcutis Biotherapeutics (ARQT) is hosting the virtual Key Opinion Leader (KOL) event on Monday, July 29, 2024, at 8:30am ET.

What topics will be covered in Arcutis' (ARQT) KOL event for ZORYVE® cream?

The KOL event will cover the unmet needs and current treatment landscape for atopic dermatitis, ZORYVE's differentiating features, and Arcutis' commercialization plans for the newly approved treatment.

Who is the target patient group for Arcutis' (ARQT) newly approved ZORYVE® cream?

ZORYVE® (roflumilast) cream 0.15% is approved for the treatment of mild to moderate atopic dermatitis in adults and children down to age 6.