(BUSINESS WIRE)--Galderma (SIX: GALD), the pure-play dermatology category leader, is presenting new three-year data from the ARCADIA long-term extension study, demonstrating that Nemluvio is well-tolerated and associated with sustained and continuous improvements in skin lesions, itch, sleep disturbance and quality of life in adults and adolescents with moderate-to-severe atopic dermatitis.1 The findings will be shared in an oral presentation, titled ‘Long-term safety and efficacy (up to 152 weeks) of nemolizumab in ARCADIA open-label extension study in adults and adolescents with moderate-to-severe atopic dermatitis’, at the 2026 European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, on Thursday, October 1, from 10:45-10:55 AM CET in Hall N by Dr. Matthias Augustin, an ARCADIA clinical trial investigator.
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“These three-year data provide important evidence of the long-term impact of Nemluvio, showing that improvements with Nemluvio were not only achieved but sustained over time, with durable benefits observed across skin symptoms, itch, sleep disturbance and quality of life. Coupled with a well-characterized safety profile, these findings add to the robust and growing body of evidence regarding the long-term use of Nemluvio in moderate-to-severe atopic dermatitis.”
PROFESSOR JONATHAN SILVERBERG
LEAD INVESTIGATOR OF THE ARCADIA CLINICAL PROGRAM, PROFESSOR OF DERMATOLOGY, GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES, UNITED STATES
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Three-year data show sustained disease control and symptom improvement in atopic dermatitis
The ARCADIA open-label long-term extension study assesses the long-term safety and efficacy of Nemluvio in adults and adolescents aged ≥12 years with moderate-to-severe atopic dermatitis for up to 200 weeks.1 At Week 152, Nemluvio was well-tolerated and associated with sustained improvements in skin lesions, itch, sleep disturbance and quality of life.1 Based on observed case analyses:
- Up to 91% of patients achieved at least 75% improvement in eczema severity (EASI-75), and up to 75% achieved at least 90% improvement in eczema severity (EASI-90)1
- Up to 67% of patients achieved clear or almost clear skin (IGA 0/1)1
- Up to 88% of patients achieved clinically meaningful itch relief and up to 73% achieved an itch-free or nearly itch-free state1
- Up to 92% of patients achieved clinically meaningful improvements in dermatology-related quality of life1
- The safety profile of Nemluvio remained consistent with previous findings through three years of treatment, with no new safety signals identified compared to previous long-term extension study interim analyses1,4
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“The three-year ARCADIA long-term extension data further strengthen Nemluvio’s robust evidence base, demonstrating significant and lasting improvements in skin lesions, with up to 75% of patients achieving EASI-90 at Week 152, one of the most stringent clinical endpoints, as well as in itch and quality of life outcomes. These findings underscore Galderma’s commitment to advancing innovation that addresses patients’ long-term needs.”
CHRISTOPHE PIKETTY, M.D., PH.D.
GLOBAL PROGRAM HEAD, THERAPEUTIC DERMATOLOGY
GALDERMA
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Additional findings highlight Nemluvio’s favorable long-term safety and efficacy profile in atopic dermatitis and prurigo nodularis
Additional data presented at EADV 2026 will provide further insights into Nemluvio’s long-term safety and efficacy profile. The findings will be shared in an E-poster in which Nemluvio was concluded to have a favorable and well-tolerated cutaneous (skin-related) safety profile in patients with moderate-to-severe atopic dermatitis and prurigo nodularis over two years in a post-hoc analysis of the ARCADIA and OLYMPIA long-term extension studies.5
A separate descriptive analysis of patient-reported outcomes from the OLYMPIA long-term extension study will be presented via E-poster, which indicated sustained and clinically meaningful improvements with Nemluvio across multiple dimensions of prurigo nodularis burden up to Week 148, including itch, pain, sleep disturbance and quality of life.2
Further analyses explore the impact of Nemluvio on sleep disturbance and quality of life
In addition, new analyses of data from the ARCADIA and OLYMPIA clinical trials identified clinically meaningful improvements in sleep disturbance with Nemluvio compared with placebo, while highlighting that sleep disturbance was closely linked to itch intensity and skin lesion severity.3 These data are being presented orally by Prof. Dr. Franz Legat on Thursday, October 1, from 11:15-11:25 AM CET in Hall N in a presentation titled ‘Comparative effects of itch, skin lesion severity and nemolizumab on sleep disturbance in atopic dermatitis and prurigo nodularis’.
Collectively, the data presented at EADV 2026 demonstrate Galderma’s continued investment in clinical research and add to the growing body of evidence supporting Nemluvio as an effective treatment option for patients with moderate-to-severe atopic dermatitis and prurigo nodularis. This underscores Galderma's commitment to advancing the care of chronic pruritic skin diseases and delivering meaningful outcomes for patients through science-backed innovations.
Media can find more information and resources on atopic dermatitis and prurigo nodularis in this toolkit.
About Nemluvio
Nemluvio is the first approved monoclonal antibody that specifically targets and inhibits the signaling of IL-31 – a neuroimmune cytokine that drives itch and is involved in inflammation and epidermal dysregulation in both atopic dermatitis and prurigo nodularis and in fibrosis in prurigo nodularis.6-9
Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis.10,11
Nemluvio was approved by the United States Food and Drug Administration for the treatment of adults with prurigo nodularis, and patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.8 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis in more than 40 countries around the world. Additional regulatory submissions and reviews are ongoing.
About Galderma
Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.
References
- Silverberg, et al. Long-term safety and efficacy (up to 152 weeks) of nemolizumab in ARCADIA open-label long-term extension study in adults and adolescents with moderate-to-severe atopic dermatitis. Presented at EADV 2026; September 30-October 03, 2026; Vienna.
- Stander, et al. Evolution of clinical response with long-term nemolizumab therapy in prurigo nodularis: From symptom relief to improvements in sleep and quality of life (AS-4212). Presented at EADV 2026; September 30-October 03, 2026; Vienna.
- Legat, et al. Comparative effects of itch, skin lesion severity and nemolizumab on sleep disturbance in atopic dermatitis and prurigo nodularis. Presented at the European Academy of Dermatology and Venereology Congress; September 30 – October 3, 2026; Vienna, Austria.
- Silverberg, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi:10.1016/S0140-6736(24)01203-0.
- Silverberg, et al. Long-term safety profile of nemolizumab over 2 years in moderate-to-severe atopic dermatitis and prurigo nodularis: Post-hoc analysis from ARCADIA LTE and OLYMPIA LTE trials (AS-832). Presented at EADV 2026; September 30-October 03, 2026; Vienna.
- Silverberg, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013.
- Bewley, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039-2048. doi: 10.1007/s13555-022-00782-2.
- Nemluvio® U.S. Prescribing Information. Available online. Accessed September 2026.
- Nemluvio® European Medicines Agency. Summary of Product Characteristics. Available online. Accessed September 2026.
- Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed September 2026.
- Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed September 2026.
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