FDA Approves ZORYVE® Cream for Atopic Dermatitis in Adults and Children 6+

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a prominent biopharmaceutical company, has announced the FDA's approval of its supplemental new drug application (sNDA) for ZORYVE (roflumilast) cream, 0.15%. This marks the company's third FDA approval in just two years. ZORYVE cream is designed for the treatment of mild to moderate atopic dermatitis (AD) in individuals aged six years and older. This once-daily, steroid-free cream is developed to provide rapid relief and significant reduction in itch, a primary symptom of AD, ensuring long-term disease control.

Dr. Lawrence F. Eichenfield from UC San Diego School of Medicine highlights the chronic and unstable nature of AD, which often leaves patients and caregivers struggling to manage frequent flare-ups. ZORYVE offers a new steroid-free solution that rapidly improves and controls the disease, including itch, which is often the most troubling symptom. Clinical trials have shown that nine out of ten patients experienced some improvement within four weeks, with 69% showing a clinically significant improvement.

Wendy Smith Begolka from the National Eczema Association emphasizes the profound impact of AD on quality of life and family dynamics. The introduction of ZORYVE represents a significant advancement in treatment options for millions of children and adults suffering from this serious skin disease.

Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the U.S. Itching, or pruritus, results from skin barrier dysfunction and neuroimmune dysregulation. In clinical trials, ZORYVE cream 0.15% demonstrated rapid and sustained reduction in itch, with effects noticeable within 24 hours of application. ZORYVE is a next-generation topical phosphodiesterase 4 (PDE4) inhibitor, which impacts itch-signaling nerves and inflammatory pathways directly.

Dr. Jonathan Silverberg from The George Washington University School of Medicine underscores the need for effective, safe, and well-tolerated treatments for AD, which often involves intense itch, rash, and sensitive skin. ZORYVE was developed with AD patients in mind, using a moisturizing formula free from common sensitizers and irritants, ensuring it does not further disrupt the skin barrier.

Frank Watanabe, CEO of Arcutis, expresses enthusiasm over the approval, noting that ZORYVE is designed to provide fast results and long-term disease control. The cream is expected to be widely available by the end of July, with Arcutis committed to ensuring predictable access through its ZORYVE® Direct Program.

The sNDA approval is based on positive results from multiple clinical studies, including three Phase 3 trials and a Phase 2 dose-ranging study. The INTEGUMENT-1 and INTEGUMENT-2 trials, which involved 1,337 patients, met their primary endpoints, demonstrating significant improvements in disease control and reduction in itch. Over 40% of participants achieved clear or nearly clear skin within four weeks.

ZORYVE cream 0.15% was well tolerated, with low incidence of side effects such as headache, nausea, and application site pain. An open-label extension study further supported the safety and efficacy of ZORYVE for long-term use.

ZORYVE cream 0.15% is approved for the treatment of mild to moderate AD in individuals aged six years and older, with additional formulations available for other dermatological conditions. Arcutis continues to develop its pipeline, aiming to address a range of inflammatory skin diseases.

Arcutis Biotherapeutics remains dedicated to addressing the urgent needs of those living with immune-mediated dermatological diseases, leveraging its expertise to develop innovative therapies.