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

Xsolla Releases The Xsolla Report: Mobile D2C Edition28.9.2026 15:00:00 CEST | Press release

New Data From More Than 800 Mobile Web Shops Finds Direct-to-Consumer Has Become a Standard Operating Discipline, With Top Performers Capturing More Than Half of a Title's Revenue Regardless of Studio Size Xsolla, a global commerce company, today released The Xsolla Report: Mobile D2C Edition, a new study examining how direct-to-consumer commerce is performing across mobile games. Drawing on data from more than 800 live Xsolla Web Shops alongside public market and regulatory data, the report shows that D2C has moved past the question of whether it works and into a new phase: studios seeing the strongest results are the ones treating their Web Shop as an operating discipline rather than a one-time build. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928312597/en/ Graphic: Xsolla Three themes run through the report. First, the gap between a typical Web Shop and a top-performing one is wide, and closing it has little to do

Incognito Software Systems Launches NEXA, an AI-Enabled Solution for Automated Broadband Operations28.9.2026 15:00:00 CEST | Press release

NEXA unifies network, device, service, and subscriber data to help broadband service providers identify issues earlier, improve customer experience, reduce churn, and automate operations. Incognito Software Systems, a leading global provider of service orchestration, device management, and network intelligence solutions, today introduced NEXA, an AI-driven network intelligence and automation platform that enables broadband service providers to turn operational data into action. NEXA unifies network, device, service, and subscriber data in a single intelligence layer, delivering real-time and predictive insights that help service providers identify issues sooner, better understand the subscriber experience, and take faster, more informed action across their operations. As service providers seek to differentiate beyond connectivity, subscriber experience has become a critical competitive advantage. However, networks have evolved into complex service platforms that span access, edge, cust

Volante Technologies and Circle advance stablecoin payment and settlement capabilities for financial institutions28.9.2026 15:00:00 CEST | Press release

Collaboration enables banks to integrate USDC workflows within existing multi-rail payments infrastructure Volante Technologies, the global leader in Payments as a Service (PaaS), today announced a strategic collaboration with Circle Internet Group, Inc. (NYSE: CRCL) (“Circle”), a leading internet financial platform company and the issuer of USDC1 through its regulated entities, to help financial institutions integrate stablecoin payment and settlement capabilities into their existing payment operations. Through the collaboration, Volante is bringing USDC workflows into its AI-powered Payments Platform, enabling financial institutions to evaluate how stablecoin activity can operate alongside existing payment rails, operational controls, and on- and off-ramp requirements - without requiring a separate digital asset stack. Volante clients, which include four of the top five global corporate banks and seven of the top 10 U.S. banks, will be able to evaluate key workflows, including mintin

Zayed Sustainability Prize Unveils 2027 Finalists Following Record-Breaking Global Entry28.9.2026 14:47:00 CEST | Press release

Record 10,233 submissions from 177 countries, up 32% year-on-yearFinalists are delivering practical, scalable solutions across health, food, energy, water and climate actionPrize has positively impacted more than 411 million lives worldwide From AI that can predict pregnancy complications months in advance and robots that navigate water networks, to new technologies restoring degraded soil and heat-resilient corals rebuilding reefs, the Zayed Sustainability Prize has unveiled its 2027 finalists following the most competitive cycle in its history. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928805335/en/ Members of the Zayed Sustainability Prize Jury gathered in Abu Dhabi to determine the 2027 winners and finalists (Photo: AETOSWire) A record 10,233 submissions from 177 countries were received for the 2027 cycle, a 32% increase year-on-year, reflecting the growing global reach of the UAE’s pioneering award for innovativ

ZincFive Expands Nickel-Zinc Technology into In-Rack Backup and AI Dynamic Power Solutions28.9.2026 14:05:00 CEST | Press release

Applying proven high-rate nickel-zinc technology to in-rack backup and AI-driven transient power applications ZincFive®, the leader in nickel-zinc (NiZn) battery-based solutions for immediate power applications, today announced its expansion into in-rack energy storage with the development of Battery Backup Unit (BBU) and AI Dynamic Power Module (DPM) solutions designed to address the evolving energy storage requirements of AI data centers. As AI drives higher rack power densities and increasingly dynamic workloads, data center power architectures are evolving to manage both traditional backup requirements and rapid, repeated changes in power demand. These transient loads can place significant stress on electrical infrastructure, creating a growing need for power solutions closer to the rack that can respond quickly, safely, and reliably. Today’s rack-level technologies often require tradeoffs between energy capacity and dynamic power response. Traditional BBUs are primarily designed t

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