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

WESTLAKE VILLAGE, Calif., July 22, 2024 — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a company specializing in innovative immuno-dermatology treatments, has announced a virtual Key Opinion Leader (KOL) event. This event will feature an expert in dermatology and immune-mediated skin diseases who will discuss the unmet needs and current treatments for individuals with mild to moderate atopic dermatitis (AD). The event will also cover the unique features and commercialization plans for ZORYVE® (roflumilast) cream 0.15%, which recently received FDA approval for treating AD in adults and children as young as six years old.

Atopic Dermatitis (AD) is the most prevalent form of eczema, impacting around 9.6 million children and 16.5 million adults in the United States. AD is a chronic, relapsing inflammatory condition with a genetic predisposition and can present at any stage of life. It manifests as a red, intensely itchy rash that can appear anywhere on the body, varying between children and adults. The severity and presentation of AD can change rapidly and are influenced by geographic and environmental factors.

ZORYVE® is a non-steroidal topical PDE4 inhibitor approved for treating AD, seborrheic dermatitis, and plaque psoriasis. PDE4 is an in-cell enzyme known for increasing pro-inflammatory mediators and reducing anti-inflammatory mediators. The FDA has approved ZORYVE (roflumilast) cream 0.15% for mild to moderate atopic dermatitis in individuals aged six and older. Additionally, ZORYVE cream 0.3% is approved for treating plaque psoriasis, and ZORYVE foam 0.3% is available for seborrheic dermatitis in adults and children aged nine and older.

Arcutis is currently evaluating a lower dose of roflumilast cream (0.05%) for children aged two to five with AD. The company has also completed its clinical development program for ZORYVE foam 0.3% aimed at treating scalp and body psoriasis and plans to submit a supplemental New Drug Application (sNDA) in the third quarter of 2024.

ZORYVE cream 0.3% is specifically indicated for treating plaque psoriasis, including intertriginous areas, in patients aged six and older. ZORYVE cream 0.15% is for topical treatment of mild to moderate atopic dermatitis in the same age group. ZORYVE foam 0.3% is indicated for treating seborrheic dermatitis in patients aged nine and older.

It is important to note that ZORYVE is contraindicated for patients with moderate to severe liver impairment (Child-Pugh B or C). The propellants in ZORYVE foam are flammable, so it is crucial to avoid fire, flame, and smoking during and immediately after application. Common adverse reactions for ZORYVE cream 0.3% for plaque psoriasis include diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection. For ZORYVE cream 0.15% treating atopic dermatitis, common adverse reactions include headache, nausea, application site pain, diarrhea, and vomiting. For ZORYVE foam 0.3% treating seborrheic dermatitis, common adverse reactions include nasopharyngitis, nausea, and headache.

Arcutis Biotherapeutics, Inc. is dedicated to addressing the urgent needs of individuals with immune-mediated dermatological conditions. The company has a diverse portfolio featuring three FDA-approved products and a robust pipeline with multiple clinical programs for various inflammatory dermatological conditions, including scalp and body psoriasis, atopic dermatitis, and alopecia areata. 

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