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FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
Globenewswire· 2025-10-06 12:00
ZORYVE cream 0.05% provides rapid and effective relief of mild to moderate atopic dermatitis in children ages 2 to 5 and is safe and well toleratedOnce-daily, steroid-free cream can be used anywhere on the body for any durationAbout 1.8 million children ages 2 to 5 with atopic dermatitis are topically treated in the U.S.Sixth FDA approval for ZORYVE in just over three yearsCommercial product expected to be available by the end of October 2025 WESTLAKE VILLAGE, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Arcut ...
Nektar Therapeutics (NasdaqCM:NKTR) FY Conference Transcript
2025-09-10 15:30
Nektar Therapeutics (NasdaqCM:NKTR) FY Conference September 10, 2025 10:30 AM ET Speaker0Get started. Good morning, everyone. Thanks for joining us today. My name is Arthur He, a senior biotech analyst at the HC Wainwright. Thanks for joining us to have a conversation with doctor Jonathan Zalevsky, chief r and d officer.A little bit about Nektar. Nektar is a global biopharmaceutical company focused on developing novel therapies that selectively moderate the immune system to treat autoimmune disorder by leve ...
Nektar Jumps 157% on Drug Trial Data—Can It Go Even Higher?
MarketBeat· 2025-06-28 12:15
Core Viewpoint - Nektar Therapeutics' stock surged nearly 157% following positive Phase 2b trial results for Rezpeg, an experimental treatment for atopic dermatitis, with analysts projecting further price increases based on market potential [1][2]. Group 1: Clinical Trial Results - Rezpeg achieved statistically significant results in a Phase 2b trial involving 393 patients, meeting both primary and secondary endpoints [4]. - The primary endpoint was the average percentage change in the Eczema Area and Severity Index (EASI) compared to placebo, with Rezpeg demonstrating a 30% average reduction in EASI scores [5]. - Up to 46% of patients experienced a dramatic decrease of at least 75% in their severity scores, a key secondary measure [5]. - Rezpeg has received Fast Track designation from the FDA, indicating its potential to address unmet medical needs [6]. Group 2: Market Potential - The eczema market is substantial, affecting an estimated 9.8 million adults and children in the U.S., representing approximately 2.8% of the total population [9]. - The market for atopic dermatitis therapies is rapidly growing, driven by high demand for effective treatments [10]. - Analysts have set price targets for Nektar's stock at $100 and $120, with a consensus price target of around $76, implying a potential upside of 212% to 349% [1][8]. Group 3: Competitive Landscape - Rezpeg faces competition from Dupixent, which has shown superior efficacy in initial measures, achieving a 50% average severity improvement compared to Rezpeg's 30% [12]. - Nektar believes Rezpeg can address underlying immune imbalances and may treat patients who do not respond to Dupixent, creating a niche market [13]. - The company plans to report 52-week results on Rezpeg in Q1 2026, which could enhance its competitive positioning against Dupixent [14].
Arcutis to Present New Long-Term Results of ZORYVE® (roflumilast) Cream at the 2025 Revolutionizing Atopic Dermatitis Conference
Globenewswire· 2025-06-06 12:00
Core Insights - Arcutis Biotherapeutics, Inc. is presenting five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, showcasing new data on the long-term safety and efficacy of ZORYVE cream in treating atopic dermatitis (AD) in children aged 2 to 5 [1][2] Group 1: Study Findings - The INTEGUMENT-OLE study demonstrated that ZORYVE cream 0.05% has long-term safety and durable efficacy in children aged 2 to 5 with AD, with a median duration of disease control of 238 days for those switching to a proactive twice-weekly application [2][5] - In the study, 32.7% of participants aged 6 years and older and 28.8% of participants aged 2 to 5 achieved a validated Investigator Global Assessment (vIGA-AD) score of clear or almost clear by Week 4, improving to 55.7% and 63.1% respectively by Week 52 [3][5] - Significant improvements in itch were observed, with 30.9% of participants aged 6 years and older and 41.2% of participants aged 2 to 5 achieving a clinically meaningful reduction in itch at the conclusion of the parent studies, improving to 55.3% and 60.7% respectively after up to 56 weeks of treatment [3][5] Group 2: Clinical Implications - The data highlight the critical need for effective, long-term, steroid-free treatment options for young children with AD, as chronic use of topical steroids can lead to significant adverse events [4][5] - ZORYVE cream formulations were well tolerated, with treatment-related adverse events reported in 4.7% of participants aged 6 years and older and 2.5% of participants aged 2 to 5 [4][5] - The investigational ZORYVE cream 0.05% is currently under FDA review, with a target action date of October 13, 2025, indicating potential for future market introduction [13]
Lilly's EBGLYSS® (lebrikizumab-lbkz) single monthly maintenance injection achieved completely clear skin at three years in half of patients with moderate-to-severe atopic dermatitis
Prnewswire· 2025-03-07 13:30
Core Insights - Eli Lilly's EBGLYSS has shown significant long-term efficacy in treating moderate-to-severe atopic dermatitis, with 50% of patients achieving complete skin clearance and 87% achieving almost-clear skin after three years of treatment [1][20][24] - The drug was approved in the U.S. as a first-line monotherapy biologic treatment option in September 2024, following topical therapies [1][20] - EBGLYSS is an interleukin-13 (IL-13) inhibitor that effectively targets the inflammatory processes associated with atopic dermatitis [1][19] Efficacy and Study Results - In the ADjoin long-term extension study, 50% of patients receiving once-monthly maintenance doses achieved complete skin clearance (EASI 100 or IGA 0) at three years, while 87% maintained almost-clear skin (EASI 90) [1][5] - Over 83% of Week 16 responders did not require concomitant therapies such as topical corticosteroids during the study [1] - Additional studies (ADmirable and ADapt) demonstrated significant improvements in itch, skin pain, and sleep loss due to itch among diverse patient groups [1][26][27] Safety Profile - The safety profile of EBGLYSS in recent studies was consistent with previous Phase 3 studies, with no new safety signals reported [2] - Most adverse events were mild or moderate, with conjunctivitis and injection-site reactions being the most common treatment-related side effects [2] Market Position and Development - EBGLYSS is the only first-line biologic treatment option for patients with moderate-to-severe atopic dermatitis uncontrolled by topical therapies, offering a once-monthly maintenance dosing regimen [3][20] - Eli Lilly has exclusive rights for the development and commercialization of EBGLYSS in the U.S. and other regions outside Europe, while Almirall holds rights for European dermatology indications [3][20] Future Directions - Further data from the ADmirable study, focusing on patients with skin of color, is expected to be shared in 2025, indicating ongoing commitment to diverse patient populations [19][26]