Galderma's Nemluvio ® (nemolizumab) Receives National Institute for Health and Care Excellence (NICE) Recommendation for Moderate-to-severe Atopic Dermatitis in England and Wales

Business Wire

a day ago

LONDON--(BUSINESS WIRE)--Galderma today announced that nemolizumab has been recommended for routine funding on the National Health Service in England and Wales for moderate-to-severe atopic dermatitis in final draft guidance from the National Institute for Health and Care Excellence. 1 This follows its recent marketing authorisation by the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years and older with a body weight of at least 30 kg, who are candidates for systemic therapy. 2
'Additional advances are needed in the treatment of atopic dermatitis due to the heterogeneity of the disease. Nemolizumab addresses this need for treatments with a favourable safety profile that effectively target both itch and skin lesions – two of the most burdensome symptoms of this disease – and we are delighted that patients in England and Wales will now have access to it.'
GALDERMA
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Nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signalling of IL-31. 2 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis. 5,9,10 It is also the first and only biologic approved for atopic dermatitis with four-week dosing intervals from the start of treatment. 2 After 16 weeks of treatment, for patients who achieve clinical response, the recommended maintenance dose of nemolizumab is 30 mg every eight weeks. 2
The approval was based on results from the phase III ARCADIA clinical trial program. The phase III ARCADIA 1 and ARCADIA 2 trials met their co-primary endpoints and all key secondary endpoints, demonstrating that nemolizumab, administered subcutaneously every four weeks in combination with background topical corticosteroids, with or without topical calcineurin inhibitors (+TCS/TCI), clinically improved skin lesions, and rapidly and significantly improved itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis, when compared to placebo +TCS/TCI. 3 Significant itch relief was observed as early as Week 1. 3 Nemolizumab was generally well tolerated in all trials. 3,10 It does not require preliminary laboratory evaluations or monitoring during treatment. 2
'It is hugely positive to have a new treatment option available for atopic dermatitis patients that can help to ease the relentless and unforgiving burden this disease can have on their lives. Nemolizumab will be an important addition to the current treatment landscape with its novel mode of action and infrequent dosing regime.'
DR ANDREW PINK
CONSULTANT DERMATOLOGIST
GUY'S AND ST THOMAS' NHS FOUNDATION TRUST
LONDON, UNITED KINGDOM
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Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease which affects approximately 1.6 million people in the UK. 4-8 Often reported as one of patients' most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians. Atopic dermatitis can also be associated with several comorbid conditions, namely mental health disorders and other autoimmune- or immune-mediated diseases. 11-14 Given the significant burden of these symptoms and the heterogeneity of the disease, there is a need for additional treatment options with a favourable safety profile that effectively target both itch and skin lesions. 5,11,15
'Relentless itch makes life so difficult for the many people living with moderate-to-severe atopic eczema (atopic dermatitis) in the UK. It disrupts sleep and impacts people's ability to concentrate throughout the day. This is in addition to the painful physical symptoms of inflamed, sore, cracked and bleeding skin. National Eczema Society welcomes the NICE decision to recommend nemolizumab for treating moderate-to-severe atopic dermatitis. It's really important we have a range of treatment options, so patients have the chance of accessing a treatment that works effectively for them.'
ANDREW PROCTOR
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About nemolizumab
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, as well as pruritus associated with atopic dermatitis in paediatric, adolescent, and adult patients. 16,17
About the ARCADIA clinical trial program 18,19
The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2.
These global, randomized, multicentre, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroids with or without topical calcineurin inhibitors).
The trials were conducted in adolescent (12 years and over) and adult patients with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks. Patients who responded to treatment (defined as patients who achieved an investigator's global assessment score of clear (0) or almost clear (1), or a 75% or greater improvement in the eczema area and severity index score) were then re-randomized to a maintenance treatment phase for up to 48 weeks.
About atopic dermatitis
Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions. 4-6 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis. 5,20
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
NICE. Nemolizumab for treating atopic dermatitis - technology appraisal guidance. Available online. Accessed June 2025
Nemolizumab. UK summary of product characteristics 2025. Available online. Accessed June 2025
Silverberg J, 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
Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: https://doi.org/10.3390/ijms21082867
Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286-1
Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi: 10.1056/NEJMra2023911
Kleyn E, et al. Prevalence and treatment patterns of adult atopic dermatitis in the UK Clinical Practice Research Datalink. Skin Health and Disease. 2023;3(4):e232. doi:10.1002/ski2.232
UK Office for National Statistics - national population projections: 2021-based interim. Available online. Accessed June 2025
Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi:10.1002/cti2.1390
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
Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi: 10.1016/j.anai.2018.07.006
Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7:102:adv00830. doi: 10.2340/actadv.v102.3932
Durno N, et al. Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi: 10.1080/09546634.2024.2417966
Penton H, et al. Assessing Response in Atopic Dermatitis: A Systematic Review of the Psychometric Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3
Lobefaro F, et al. Atopic Dermatitis: Clinical Aspects and Unmet Needs. Biomedicines. 2022;10:2927. doi: 10.3390/biomedicines10112927
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 June 2025
Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed June 2025
ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03985943). Available online. Accessed June 2025
ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03989349). Available online. Accessed June 2025
Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi: 10.7861/clinmed.2021-0257