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

Samos Energy Acquisition Corporation Announces Pricing of Initial Public Offering10.7.2026 15:32:00 CEST | Press release

Samos Energy Acquisition Corporation (the “Company”) announced today the pricing of its initial public offering (“IPO”) of 20,000,000 units at a price of $10.00 per unit. The units will be listed on the New York Stock Exchange (the “NYSE”) and trade under the ticker symbol “SAMO.U” beginning on July 10, 2026. Each unit consists of one Class A ordinary share and one-half of one redeemable warrant, with each whole warrant entitling the holder thereof to purchase one of the Company’s Class A ordinary shares at an exercise price of $11.50 per share. Once the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on the NYSE under the symbols “SAMO” and “SAMO.WS,” respectively. Cantor Fitzgerald & Co. is acting as the sole book running manager for the proposed offering. The Company has granted the underwriter a 45-day option to purchase up to an additional 3,000,000 units at the IPO price. The public offering is being made

Onera hPSG® Wins Prestigious Red Dot Product Design Award10.7.2026 15:00:00 CEST | Press release

Onera Health's patch-based home polysomnography solution, Onera hPSG®, was awarded the renowned ‘Red Dot Award: Product Design 2026’ in recognition of the sensors’ innovative design, advanced functionality, and user-centric engineering. Onera Health, a leader in transforming sleep medicine, announces that its innovative product, Onera hPSG®, has been honoured with the prestigious Red Dot Product Design Award for 2026. This international recognition celebrates exceptional design quality and underscores Onera Health's commitment to excellence, creativity, and patient-centric innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260710266668/en/ Onera Health's patch-based home polysomnography solution, Onera hPSG®, wins Prestigious Red Dot Product Design Award 2026. The Red Dot Award, one of the most sought-after seals of quality for good design, attracted thousands of entries from around the globe. Onera hPSG® stood out f

teamLab Biovortex Kyoto Welcomes Over 1 Million Visitors within 9 Months of Opening10.7.2026 09:00:00 CEST | Press release

teamLab Biovortex Kyoto has welcomed over 1 million visitors as of July 6, 2026, 9 months after its grand opening. (*1) These visitors arrived from more than 150 countries and regions. International visitors account for approximately 42% of the total. Many of these international visitors travel from distant countries and regions, including the United States, Australia, Canada, the United Kingdom, and Germany. Approximately 30% of these international visitors purchase their tickets at least 30 days in advance. teamLab Biovortex Kyoto is teamLab's largest museum in Japan, with an average visitor stay of over two and a half hours. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709913938/en/ teamLab Biovortex Kyoto Welcomes Over 1 Million Visitors within 9 Months of Opening *1 According to ticket purchase data from the official teamLab Biovortex Kyoto website (survey period: October 7, 2025 – July 6, 2026) Visitors Comment (M

Robbyant Launches LingBot-VA 2.0 Built Natively for Embodied AI and Physical World Control10.7.2026 08:48:00 CEST | Press release

Robbyant, an embodied AI company within Ant Group, today announced the release of LingBot-VA 2.0, the industry’s first embodied-native video-action world model. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709654440/en/ A robot powered by LingBot-VA 2.0 engages in a real-time tabletop air hockey match with a human This release marks a key transition in robotics foundation models, shifting from repurposing digital world models to designing them natively for the physical world. Instead of relying on fine-tuned digital content generation models, LingBot-VA 2.0 is built from scratch to meet the original demands of dynamic modeling, causal prediction, and real-time execution in physical environments. Integrating world models with embodied AI has been one of the major focuses of the AI industry. However, most mainstream approaches rely on video generation models designed for digital content, which are then fine-tuned for robo

SureWerx Appoints Erik Pertot as VP/GM SureWerx EMEA10.7.2026 08:00:00 CEST | Press release

Experienced global PPE leader to strengthen portfolio strategy, operational execution, and growth across SureWerx’s international platform SureWerx, a leading global manufacturer of personal protective equipment, safety products, tools and equipment solutions, today announced the appointment of Erik Pertot as VP/GM SureWerx EMEA. Pertot will report directly to CEO Scott Dowell and will lead growth, manufacturing and M&A activities in Europe across the company’s global portfolio. Erik joins SureWerx with more than 20 years of international leadership experience across engineering, quality, marketing, sales, international supply chain, product management, and general management. He brings deep expertise in the personal protective equipment industry, with a track record of leading complex, compliance-critical programs, managing business transitions, and driving growth across multinational environments. Most recently, Pertot served as Global General Manager for Footwear and Fall Protection

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