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Arcutis to Host ZORYVE (Roflumilast) Cream 0.15% FDA Approval Call With KOL
Globe Newswire 22-Jul-2024 8:00 AM
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%).
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
