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

FDA Authorizes ZYN ULTRA Nicotine Pouches Following Scientific Review21.8.2026 21:11:00 CEST | Press release

Authorizations add selection of ZYN ULTRA products to PMI U.S.’s growing portfolio of better alternatives for legal-age adults who smoke or use traditional oral tobacco products Philip Morris International Inc. (NYSE: PM) today announces that the U.S. Food and Drug Administration (FDA) issued Marketing Granted Orders to PMI’s U.S. affiliate, Swedish Match USA, Inc., authorizing the marketing of 11 ZYN ULTRA moist oral nicotine pouch products, including all 9mg variants and one 11mg variant. Additional 11mg variants remain under scientific review. Today’s action further enhances PMI’s leadership role in the smoke-free category. “We are delighted with the FDA’s decision to authorize a range of ZYN ULTRA products, which will build on ZYN’s position as America’s leading smoke-free product brand,” said Stacey Kennedy, PMI U.S. CEO. “We look forward to expanding our portfolio of better choices for the 45 million Americans who consume nicotine products.” ZYN ULTRA positions the brand to furth

58% of Consumers Say They Don't Care Whether a Product is a National Brand or Private Label. They Just Buy What They Need21.8.2026 12:00:00 CEST | Press release

New NIQ & World Data Lab report reveals how consumer polarization is redefining value, accelerating private label adoption, and reshaping competition on the shelf As fast-moving consumer goods (FMCG) prices rose 26% globally between 2021 and 2025, consumers have become more deliberate about where they save and where they spend. NielsenIQ (NYSE: NIQ) has released new findings showing that private label is no longer viewed simply as a lower-cost substitute, but as a credible competitor across value, mainstream, and premium segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260819950224/en/ Private label is no longer just a value play. The findings, published in NIQ’s latest report, A Tale of Two Consumers: The Polarized Mindsets Reshaping Global Consumption, created in collaboration with World Data Lab, show how consumer polarization is redefining value and reshaping competition on the shelf. The report also draws on ins

Tanium Reappoints Co-Founder Orion Hindawi as CEO to Drive Next Chapter of Growth20.8.2026 21:10:00 CEST | Press release

Company to focus on deepening its Autonomous IT capabilities, further expanding AI offerings across its portfolio, and strengthening customer and partner engagement Tanium, a leader in Autonomous IT, today announced that Co-Founder and Executive Chairman Orion Hindawi has been appointed Chief Executive Officer, effective immediately. Dan Streetman is stepping down as CEO and as a member of the Board after leading Tanium for the last three years, during which time Tanium scaled its go-to-market operations and secured strong industry analyst recognition for innovation within the Tanium platform. Streetman will continue to advise Tanium as part of the transition and co-founder David Hindawi will return to the role of Chairman of the Board. With this foundation in place, this transition positions Tanium to deepen its Autonomous IT capabilities and further expand AI offerings across its portfolio and strengthen customer and partner engagement. The Hindawis co-founded Tanium in 2007 to build

PCI Energy Solutions to Join Mitsubishi Electric, Reinforcing Long-Term Commitment to Customers, Employees, and the Energy Industry20.8.2026 19:46:00 CEST | Press release

Mitsubishi Electric to retain PCI’s core management team and support continuity of operations, customer service, and product innovation PCI Energy Solutions ("PCI"), a leading U.S.-based provider of enterprise software for energy management and optimization, announced today that it has entered into a definitive agreement to be acquired by Mitsubishi Electric Corporation. The agreement was executed on August 20, 2026 (Japan Standard Time). The Transaction represents a strong endorsement of PCI's business, technology, employees, customer relationships and position in the energy industry. Mitsubishi Electric intends to retain PCI's core management team following completion of the Transaction, enabling PCI to preserve leadership continuity, industry expertise and its customer-focused operating model while benefiting from Mitsubishi Electric's global scale, complementary capabilities and long-term investment capacity. The agreement has been signed, but the Transaction has not yet closed. PC

Perma-Pipe Secures More Than $67 Million in New Orders in the Second Quarter of 202620.8.2026 19:02:00 CEST | Press release

Awards include significant Oil & Gas projects in MENA and Canada, as well as the Company's largest single leak detection project to date and continued growth at its new Ohio facility. Perma-Pipe International Holdings, Inc. (Nasdaq: PPIH), a global leader in engineered piping and corrosion protection solutions, today announced that the Company secured more than $67 million in new orders during the second quarter of fiscal 2026, representing strong demand across its strategically important end-markets and geographies. The orders further strengthen Perma-Pipe's backlog and provide increased visibility into future revenue growth. The Company's backlog remains well diversified across geographies, customers and end-markets. The Company continued to see strong demand across its core Oil & Gas and infrastructure markets, while also securing important new business in emerging applications, including advanced leak detection and monitoring solutions. During the quarter, Perma-Pipe secured sizabl

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