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AbbVie to Highlight New Clinical and Real-World Evidence Advancing Standards of Care in Immune-Mediated Skin Diseases at the 2026 AAD Annual Meeting
Prnewswire· 2026-03-27 14:00
Core Insights - AbbVie is set to present new research at the 2026 American Academy of Dermatology (AAD) Annual Meeting, showcasing advancements in standards of care for immune-mediated skin diseases [1][2] Group 1: Research Highlights - AbbVie will present 24 abstracts, including a late-breaking presentation, emphasizing its leadership in immune-mediated skin diseases [2] - The clinical evidence demonstrates durable treatment responses, long-term safety, and quality of life improvements across various dermatologic diseases [2][3] - Key findings include the long-term efficacy of risankizumab in maintaining radiographic non-progression in psoriatic arthritis, with 88% of patients showing no progression over five years [5] Group 2: Quality of Life Improvements - Data indicates significant quality of life improvements for patients with atopic dermatitis and psoriasis, with risankizumab showing high efficacy in treating these conditions [4][6] - In the UnlIMMited trial, 72% to 88.9% of patients with genital psoriasis achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1 after 16 weeks of treatment [6] - Real-world evidence from the AD-VISE study shows that 72.3% of patients achieved minimal disease activity with upadacitinib treatment [5][9] Group 3: Investigational Data - Phase 3 data for upadacitinib in treating non-segmental vitiligo and severe alopecia areata will be presented, highlighting its potential efficacy [8][9] - The investigational studies show a greater proportion of patients achieving significant improvements in disease severity compared to placebo [8][9] - Upadacitinib is currently not FDA approved for vitiligo and alopecia areata, indicating ongoing research and development in these areas [8][9]
FDA Accepts Supplemental New Drug Application for Arcutis' ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5
Globenewswire· 2025-11-17 13:00
Core Viewpoint - Arcutis Biotherapeutics announced the FDA's acceptance of a supplemental New Drug Application for ZORYVE® cream 0.3%, aiming to expand its indication for treating plaque psoriasis in children aged 2 to 5 years, with a target action date set for June 29, 2026 [1][6]. Company Overview - Arcutis Biotherapeutics is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a commitment to addressing the needs of individuals with immune-mediated skin diseases [7]. - The company has developed a portfolio of advanced targeted topicals approved for treating major inflammatory skin diseases [7]. Product Information - ZORYVE cream 0.3% is a topical phosphodiesterase-4 (PDE4) inhibitor, currently approved for plaque psoriasis in adults and children aged 6 and older [1][8]. - If approved for younger children, ZORYVE would be the first and only topical PDE4 inhibitor indicated for this age group, providing a steroid-free treatment option [2][6]. Clinical Data - The supplemental New Drug Application is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study and a long-term open-label study, demonstrating favorable safety and tolerability in children aged 2 to 5 years [2][3]. Market Context - Plaque psoriasis affects nearly 9 million people in the U.S., with treatment challenges particularly pronounced in young children due to the sensitive areas affected [3]. - ZORYVE cream is recognized as the number one prescribed branded topical therapy for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis [4]. Recognition and Awards - ZORYVE has received multiple awards, including the "2025 Best of Beauty Breakthrough Award" from Allure and the National Psoriasis Foundation's Seal of Recognition, highlighting its clinical impact and industry recognition [5].