ZUG, Switzerland -
New Nemluvio® (nemolizumab) post-hoc data from the ARCADIA long-term extension (LTE) study showed the majority of Week 16 responders maintained deep and lasting skin lesion and itch response for up to three years1
Additional long-term data further demonstrate Nemluvio’s consistent safety profile and sustained efficacy, including improvements in skin clearance, itch, sleep and quality of life in adults with prurigo nodularis up to 148 weeks, and people with atopic dermatitis aged 12 and older up to 152 weeks2,3
Phase II pediatric data will also be presented, with nemolizumab driving meaningful and sustained improvements in children aged 2-11 years with moderate-to-severe atopic dermatitis4
Alongside a product theatre exploring how targeted IL-31 treatment may impact patient outcomes, these findings reinforce Galderma's leadership in advancing treatment goals in atopic dermatitis and prurigo nodularis
(BUSINESS WIRE)--Galderma (SIX: GALD), the pure-play dermatology category leader, today announced new data regarding the use of Nemluvio for atopic dermatitis and prurigo nodularis to be presented at the 2026 Fall Clinical Dermatology Conference, taking place from October 08-11 in Las Vegas, United States. This includes a new post-hoc analysis from the ARCADIA LTE study showing that in adults and adolescents aged 12 and older who achieved an early response at Week 16 in the ARCADIA trial, Nemluvio achieved deep and lasting skin lesion and itch responses for up to three years.1 The data add to the growing evidence supporting the long-term efficacy of Nemluvio, underscoring Galderma's commitment to advancing the science for people living with moderate-to-severe atopic dermatitis and prurigo nodularis.
“Patients and physicians increasingly expect more from treatment than temporary symptom relief. The data presented at Fall Clinical reinforce our confidence in Nemluvio's potential to deliver durable disease control, with evidence spanning deep and sustained responses on skin and itch through three years in adults and adolescents, and a consistent long-term safety and efficacy profile. Together, these findings reflect Galderma's continued focus on redefining what is possible for people living with atopic dermatitis and prurigo nodularis.”
BILL ANDRIOPOULOS, PH.D.
HEAD OF GLOBAL MEDICAL AFFAIRS
GALDERMA
Majority of ARCADIA Week 16 early responders maintained deep and lasting skin lesion and itch responses with Nemluvio through three years1
New post-hoc data from the ongoing ARCADIA LTE study showed that adults and adolescents aged ≥12 years with moderate-to-severe atopic dermatitis who achieved an early clinical response with Nemluvio in the ARCADIA trials, were able to maintain deep and lasting improvements in both skin lesions and itch response through Week 152.1 The analysis evaluated 295 patients who achieved a clinical response at Week 16 and continued treatment during the maintenance and LTE phases of the study.1 Deep skin clearance was assessed by the proportion of participants achieving an IGA score of 0 or 1, and those with a more than 90% or 100% improvement from the initial baseline in the EASI score.1
Among these early responders at one year (Week 56), 77% achieved clear skin or at least a 90% improvement in disease severity.1 This was maintained up to Week 152, where 76% achieved clear (IGA 0) or almost clear skin (IGA 1), and 80% achieved at least a 90% improvement in disease severity (EASI-90) and 50% achieved complete skin clearance (EASI-100).1 In addition, at Week 152, 80% achieved an itch-free or nearly itch-free state.1
Nemluvio was well tolerated, with no new safety signals.1 The data are consistent with the previously collected safety and efficacy data regarding Nemluvio in adults and adolescents with moderate-to-severe atopic dermatitis.5 These findings further strengthen the growing body of evidence supporting the long-term efficacy of Nemluvio and its potential to deliver lasting disease control across key symptoms of atopic dermatitis.
“As progress in this high-burden disease area accelerates, we are challenged to aim higher in atopic dermatitis care. These new three-year results are encouraging for Nemluvio, adding to its growing body of evidence and highlighting its potential to help patients achieve meaningful long-term outcomes in atopic dermatitis.”
SARINA ELMARIAH, M.D.
DERMATOLOGIST AND ITCH SPECIALIST
UNIVERSITY OF CALIFORNIA
SAN FRANCISCO, UNITED STATES
Separate three-year interim analysis from the ARCADIA LTE reinforces the long-term benefit of Nemluvio2
A separate pre-specified interim analysis of the overall ARCADIA LTE population assessed the long-term safety and efficacy of Nemluvio in 1,903 adults and adolescents aged ≥12 years with moderate-to-severe atopic dermatitis.2 At Week 152, Nemluvio was well-tolerated and associated with sustained efficacy, including improvements in skin lesions, itch, sleep disturbance and quality of life.2 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)2
Up to 67% of patients achieved clear or almost clear skin (IGA 0/1)2
Up to 88% of patients achieved clinically meaningful itch relief and up to 73% achieved an itch-free or nearly itch-free state2
Up to 92% of patients achieved clinically meaningful improvements in dermatology-related quality of life2
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 analyses2,5
Pediatric data support nemolizumab’s potential across patient populations4
Galderma will also present clinical results from a phase II study designed to assess the pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis.4 Results showed that nemolizumab pediatric doses were associated with similar pharmacokinetic exposure compared to adults and adolescents, and were well tolerated and effective in children, with clinically meaningful reductions in skin lesions and itch through Week 16 and sustained up to Week 52.4
Long-term data reinforce sustained improvements in prurigo nodularis burden3
A separate descriptive analysis from the OLYMPIA LTE study showed that Nemluvio also delivered sustained and clinically meaningful improvements across multiple dimensions of prurigo nodularis burden through Week 148, including itch, pain, sleep disturbance, quality of life and overall health status.3 At Week 48, out of 508 enrolled patients:
More than 85% of patients achieved clinically meaningful itch improvement, with about three-quarters of patients achieving an itch-free or nearly itch-free state3
60% reported no prurigo nodularis-associated pain3
85% achieved clinically meaningful improvements in sleep disturbance3
91% experienced clinically meaningful improvements in quality of life3
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 analyses3
These findings reinforce that long-term treatment with Nemluvio may support not only symptom relief, but also meaningful improvements in patients' daily functioning and wellbeing.
Also at the Fall Clinical 2026 congress, Dr. Raj Chovatiya and Dr. Shawn Kwatra will present to healthcare professionals attending the congress at a Galderma-sponsored product theatre titled “Targeting the IL-31 Neuroimmune Pathway: A Case-Based Approach.” Taking place on Friday, October 9, from 12:30-1:00 PM in the Castillon room, the session will explore the role of neuroimmune interactions in prurigo nodularis and atopic dermatitis, discussing real-world cases and the potential impact of targeting the IL-31 pathway on patient outcomes.
Media can find more information and resources on atopic dermatitis and prurigo nodularis in this toolkit.
About nemolizumab
Nemolizumab 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, epidermal dysregulation and fibrosis in both atopic dermatitis and prurigo nodularis.6-9
Nemolizumab 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 in adults and children aged 13 years and older, as well as pruritus associated with atopic dermatitis in adults and children between the ages of 6 and 12.10,11
Nemolizumab (under the name 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.7 To date, nemolizumab is approved for both adolescents and adults with moderate-to-severe atopic dermatitis and adults with prurigo nodularis in more than 40 countries around the world. Additional regulatory submissions and reviews are ongoing.
Nemluvio Important Safety Information
INDICATIONS: NEMLUVIO® (nemolizumab-ilto) is an interleukin-31 receptor alpha antagonist indicated for:
the treatment of adults and pediatric patients 12 years of age 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.
the treatment of adults with prurigo nodularis.
CONTRAINDICATION: NEMLUVIO is contraindicated in patients with known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO.
WARNINGS AND PRECAUTIONS: Hypersensitivity reactions have been reported with NEMLUVIO use. If clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy, and discontinue NEMLUVIO. Avoid use of live vaccines during treatment with NEMLUVIO.
ADVERSE REACTIONS: Most common adverse reactions (incidence ≥1%) are:
Atopic Dermatitis: headache (including migraine), arthralgia, urticaria, and myalgia.
Prurigo Nodularis: headache, dermatitis atopic, eczema, and eczema nummular.
USE IN SPECIFIC POPULATIONS:
Pregnancy: There are no adequate and well-controlled studies on NEMLUVIO in pregnant women. The limited available information on NEMLUVIO use during pregnancy is not sufficient to inform a drug-associated risk of major birth defects or miscarriage in humans. Human IgG antibodies are known to cross the placental barrier; therefore, NEMLUVIO may be transmitted from the mother to the developing fetus.
Lactation: There are no data on the presence or transfer of NEMLUVIO in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. The effects of local gastrointestinal and limited systemic exposure to NEMLUVIO on the breastfed infant are unknown. NEMLUVIO has not been administered to nursing/lactating women. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEMLUVIO and any potential adverse effects on the breastfed child from NEMLUVIO or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of NEMLUVIO have not been established in pediatric patients younger than 12 years of age for the treatment of moderate-to-severe atopic dermatitis or pediatric patients younger than 18 years of age for the treatment of prurigo nodularis.
Please see full Prescribing Information including Patient Information.
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
1. Elmariah, et al. Nemolizumab treatment is associated with deep and lasting skin lesion and itch responses: Results from the ARCADIA long-term-extension (LTE) study up to week 152. Presented at Fall Clinical Dermatology Conference 2026; October 8-11, 2026; Las Vegas.
2. 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 Fall Clinical Dermatology Conference 2026; October 8-11, 2026; Las Vegas.
3. 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 Fall Clinical Dermatology Conference 2026; October 8-11, 2026; Las Vegas.
4. Eichenfield, et al. Pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2-11 years) with moderate-to-severe atopic dermatitis. Presented at AAD 2026; March 27-31, 2026.
5. 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.
6. Silverberg JI, 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
7. Nemluvio U.S. Prescribing Information. Available online. Accessed March 2025
8. Nemluvio European Medicines Agency. Summary of Product Characteristics. Available online. Accessed March 2025
9. Bewley A, 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
10. 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 March 2025.
11. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed March 2025.
View source version on businesswire.com: https://www.businesswire.com/news/home/20261007414473/en/
Permalink
https://www.aetoswire.com/en/news/54617802
Contacts
For further information:
Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50
Richard Harbinson
Corporate Communications Director
richard.harbinson@galderma.com
+41 76 210 60 62
Céline Buguet
Franchises and R&D Communications Director
celine.buguet@galderma.com
+41 76 249 90 87
Emil Ivanov
Head of Strategy, Investor Relations, and ESG
emil.ivanov@galderma.com
+41 21 642 78 12
Jessica Cohen
Investor Relations and Strategy Director
jessica.cohen@galderma.com
+41 21 642 76 43
