Business Wire

Galderma’s Nemluvio® (Nemolizumab) Granted Marketing Authorization in the United Kingdom and Switzerland for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis

18.2.2025 07:00:00 CET | Business Wire | Press release

Share

These are the first approvals of nemolizumab from countries within the Access Consortium framework, with regulatory review processes ongoing in the remaining countries – Australia and Singapore Nemolizumab, which is also approved in the EU and U.S., is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31 – a neuroimmune cytokine that drives itch and other symptoms in both moderate-to-severe atopic dermatitis and prurigo nodularis1-6

Galderma today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency and Swissmedic have granted the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the UK and Switzerland, respectively. Specifically, the approvals are for nemolizumab’s subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years of age and older with a body weight of at least 30kg, who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.7,8

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250217972666/en/

These are the first approvals from countries within the Access Consortium framework, an international collaborative initiative comprised of regulatory authorities which work together to address shared challenges. Decisions in the remaining countries within the Access Consortium, Australia and Singapore, are expected later this year. Nemolizumab is also approved in the European Union and United States for both moderate-to-severe atopic dermatitis and prurigo nodularis.5,6 Galderma’s leadership in Therapeutic Dermatology is evidenced by the recent regulatory approvals of nemolizumab, and its ongoing commitment to bringing this novel treatment to millions of patients around the world.

Atopic dermatitis and prurigo nodularis are debilitating skin conditions that affect up to 1.6 million and 18,000 people in the UK, respectively, and 450,000 people altogether in Switzerland.9-14 There is a need for new treatment options for these diseases to effectively relieve the signs and symptoms such as persistent itch, skin lesions and poor sleep quality.1,2,15-17 Itch is one of the most burdensome symptoms of both conditions, with 87% of patients with atopic dermatitis saying that they are seeking freedom from itch, and 88% of patients with prurigo nodularis rating itch as their worst symptom.18,19

 

“These approvals offer patients with moderate-to-severe atopic dermatitis and prurigo nodularis a much-needed novel treatment option, given the potential burden and negative impact on quality of life associated with these conditions. I am looking forward to offering my patients this new treatment option which has the potential to address their most troublesome symptoms.”

 

DR. CURDIN CONRAD

PROFESSOR OF DERMATOLOGY

LAUSANNE UNIVERSITY HOSPITAL, SWITZERLAND

 

 

Nemolizumabis the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.3 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis, and in fibrosis in prurigo nodularis.1-4

This approval is based on robust results from the phase III ARCADIA and OLYMPIA clinical trial programs, which demonstrated that nemolizumab clinically improved skin lesions, itch, and sleep disturbance in atopic dermatitis and prurigo nodularis, respectively.20-22 Nemolizumab was well tolerated in both clinical trial programs, and its safety profile was generally consistent with earlier data, and between trials.3,20-22

 

“Nemolizumab’s continued regulatory success underscores Galderma’s strong leadership in Therapeutic Dermatology, and our commitment to bringing innovative treatments to the patients. Its approval in the UK and Switzerland was driven yet again by robust data from the ARCADIA and OLYMPIA clinical trial programs, which show that nemolizumab has the potential to improve some of the most debilitating symptoms of both moderate-to-severe atopic dermatitis and prurigo nodularis.”

 

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.

GLOBAL HEAD OF R&D

GALDERMA

 

 

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. 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
  2. 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
  3. 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
  4. 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
  5. Nemluvio. EU Summary of Product Characteristics 2025
  6. NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.; August 2024
  7. Nemolizumab. UK summary of product characteristics 2025
  8. Nemluvio. Swissmedic medicinal product information 2025
  9. 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
  10. Morgan C, et al. Epidemiology of prurigo nodularis in England: a retrospective database analysis. British Journal of Dermatology. 2022;187(2):188–195. doi:10.1111/bjd.21032
  11. UK Office for National Statistics - national population projections: 2021-based interim. Available online. Accessed February 2025
  12. aha! Swiss Allergy Centre - Prurigo nodularis. Available online. Accessed February 2025
  13. aha! Swiss Allergy Centre - Atopic dermatitis (atopic eczema, neurodermatitis). Available online. Accessed February 2025
  14. World Health Organization. Population, Switzerland. Available online. Accessed February 2025
  15. Chisolm SS. A Review of the Current Management and Burden of Prurigo Nodularis in the United States. AJMC. 2023;29(suppl 5):S63-S72. doi:10.37765/ajmc.2023.89366
  16. Lobefaro F, et al. Atopic Dermatitis: Clinical Aspects and Unmet Needs. Biomedicines. 2022;10:2927. doi:10.3390/biomedicines10112927
  17. Katoh N, Ohya Y, Ikeda M, et al. Clinical practice guidelines for the management of atopic dermatitis 2018. J Dermatol. 2019;46(12):1053-1101. doi:10.1111/1346-8138.15090
  18. 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. PMID: 36479885; PMCID: PMC10508272
  19. Rodriguez D, et al. Patient Perspectives on Living With Severe Prurigo Nodularis. JAMA Dermatol. 2023;159(11):1205-1212. doi:10.1001/jamadermatol.2023.3251. PMID: 37728897; PMCID: PMC10512162
  20. 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
  21. Kwatra SG, et al. Placebo-controlled phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. doi:10.1056/NEJMoa2301333
  22. Ständer S, et al. Nemolizumab in Patients with Moderate-to-Severe Prurigo Nodularis: A Randomized Controlled Phase 3 Trial. JAMA Derm. 2024;160. doi: 10.1001/jamadermatol.2024.4796

View source version on businesswire.com: https://www.businesswire.com/news/home/20250217972666/en/

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Brightfin Launches Spend Clearly AI to Help Enterprise Tech Leaders Take Control of Growing IT and AI Costs6.5.2026 22:32:00 CEST | Press release

New AI-powered optimization app delivers real-time visibility, cost reduction, and predictive forecasting as enterprise AI spending accelerates Brightfin, a leader in AI native IT cost optimization, today announced the launch of Spend Clearly AI, an intelligent optimization app purpose-built for enterprise technology leaders navigating the dual pressures of rising IT complexity and rapidly escalating AI investment. As organizations race to deploy AI apps, models, and infrastructure, technology demands on the budget are expanding faster than ever and growing harder to track, justify, and control. The modern enterprise IT bill has become a moving target. Spend Clearly AI gives CIOs, CTOs, and IT finance teams a single, intelligent app to see exactly where every technology dollar is going, eliminate waste, and stay ahead of costs before they spiral. "Stop thinking about IT as a cost problem. The goal isn't just to spend less — the goal is to spend better," said Joel Martins, CEO of Bright

iQmetrix to Showcase Intelligent Commerce Operating System and Catalyst Innovation at DTW Ignite 20266.5.2026 19:20:00 CEST | Press release

Bronze sponsor debut includes Catalyst project innovation, live platform demo, and a unified AI‑native commerce vision iQmetrix, the Intelligent Commerce Operating System for telecom, announced today it will exhibit, speak, and compete as a bronze sponsor at DTW Ignite 2026 in Copenhagen from June 23–25. The company will deliver a live product demo in The Loft, showcase its ODA PRISM Catalyst project alongside a consortium of global operators and technology partners, and exhibit at Booth #317 throughout the event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260506948390/en/ The debut marks a milestone in iQmetrix’s global growth strategy and deepens its partnership with TM Forum, following its recent recognition as an ODA Component Directory Partner. The Future of Commerce Is Won at the Orchestration Layer DTW Ignite 2026’s theme, “The Future. Faster.,” captures the urgency facing communications service providers worldwid

Go Beyond the Guidebook: Why Ireland Rewards Those Who Slow Down6.5.2026 18:15:00 CEST | Press release

In a world where travel often feels rushed and driven by checklists, Ireland stands apart. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260501313521/en/ Lusty Beg Island Kesh, Co. Fermanagh The destination offers something deeper, drawing visitors beyond the expected toward richer encounters with its landscapes, culture and communities. As a compact island, Ireland gives holiday makers the chance to take in much of the destination while still travelling at a relaxed, unhurried pace. It’s a chance to slow down, not to do less, but to feel more - more calm, more connection, and more of what makes travel meaningful. This approach to travel is matched by Ireland’s natural warmth and welcome, helping visitors feel at home from the moment they arrive. Take the scenic route From the rugged coastline of the Wild Atlantic Way, one of the world’s longest coastal routes, to the rolling landscapes of Ireland’s Hidden Heartlands, Irela

TACTICA AI Introduces Region’s First AI Platform for Mission-Critical, Real-Time Operational Decisions6.5.2026 17:18:00 CEST | Press release

Built on deep tech developed by TII, TACTICA AI moves beyond dashboards to help decision-makers turn fragmented intelligence, sensor, and operational data into action Showcased during Make it in the Emirates 2026, the platform has already been validated through real-world deployments in mission-critical environments Built in Abu Dhabi, connected globally, TACTICA AI integrates partnerships with French-based Safran and Polish-based Satim TACTICA AI, an Abu Dhabi-based start-up, today introduced its multi-domain decision-support platform to a wider market during Make it in the Emirates 2026. At a time of increasing operational complexity and pressure to make faster, better-informed decisions, the platform is designed to transform fragmented intelligence, sensor, and operational data into real-time decisions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260506006177/en/ TACTICA AI Introduces Region’s First AI Platform for Mis

FlightSafety International Receives FAA Approval for Virtual Aircraft Preflight Inspection with Evaluation Mode6.5.2026 16:05:00 CEST | Press release

Three aircraft programs approved, with three more expected to receive approval in 2026 FlightSafety International Inc., the global leader in aviation training and simulation technology, today announced it has received Federal Aviation Administration (FAA) approval for Virtual Aircraft Preflight Inspection (VAPI) with Evaluation Mode for three aircraft training programs: the Embraer EMB-550, Gulfstream G500/G600, and Citation Latitude. This innovative capability allows pilots in initial training to complete a 3D virtual aircraft preflight inspection while in Training Mode, with the added ability to transition directly into the flight deck, followed by Evaluation Mode, that allows pilots to do their preflight check ride portion. “VAPI represents a meaningful advancement in training innovation,” said David Penney, VP of Safety, Courseware and Regulatory Affairs, FlightSafety International. “By leveraging an immersive 3D environment, it offers pilots a more engaging and practical way to de

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye