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

The Estée Lauder Companies Makes Strategic Minority Investment in Mexican Luxury Fragrance Brand XINÚ13.11.2025 22:50:00 CET | Press release

The Estée Lauder Companies Inc. (NYSE: EL) today announced a minority investment in XINÚ, a Mexican luxury fragrance brand inspired by the abundance and exoticism of the American continent. This investment marks the first time The Estée Lauder Companies has invested in a Latin American brand, underscoring the company’s commitment to championing local entrepreneurship and innovation. Since its founding in 2017, XINÚ has created a distinctive universe where fragrance, design, and storytelling converge. The brand is celebrated for its sensorial retail spaces, sustainable design ethos, and products that honor heritage while reimagining modern luxury. “Fragrance excellence and craftsmanship are at the heart of The Estée Lauder Companies, and they drive our passion for discovering new voices in beauty,” said Stéphane de La Faverie, President and Chief Executive Officer, The Estée Lauder Companies. “Mexico has become a vibrant hub of fragrance innovation — a place where craftsmanship and cult

Stage Set for World’s Largest Autonomous Race as A2RL Reaches Full Fan Capacity at Yas Marina Circuit13.11.2025 19:02:00 CET | Press release

15 November at Abu Dhabi’s iconic Yas Marina Circuit, in front of a full capacity crowd Eleven global teams compete for $2.25 million prize World first: Six fully autonomous cars racing head-to-head Human vs. AI showdown featuring former F1 driver Daniil Kvyat against TUM Race will be broadcast globally, this Sunday, 16th November at 3pm GST, on the Abu Dhabi Media Network, StarzPlay, Motorsport TV and the official A2RL YouTube Channel The world’s largest autonomous car race will take place in Abu Dhabi on the 15th of November, as 11 teams from across the globe compete at the frontier of robotics, autonomy and AI for a US$2.25 million prize pool. A2RL Season 2 has been 18 months in the making, with the six fastest teams making it through the tough qualification process to the Grand Final. Ticket allocation for the Yas Marina Circuit event has once again reached full capacity of the main grandstand, as motorsport and technology enthusiasts excitedly prepare to witness an AI competition

TRU Simulation announces delivery and acceptance of the Bell 505 Flight Training Device to Royal Jordanian Air Force13.11.2025 16:00:00 CET | Press release

TRU Simulation + Training Inc., a Textron Inc. (NYSE:TXT) company, and an affiliate of Bell Textron Inc. today announced delivery and acceptance of the Bell 505 Flight Training Device (FTD) to the Royal Jordanian Air Force (RJAF). The purchase agreement with the RJAF includes aircraft delivery complete with a flight training device and a comprehensive computer-based training package to support basic and advanced rotorcraft flight training at the King Hussein Air College in Mafraq, Jordan. This milestone follows the recent delivery of 10 Bell 505 helicopters to the RJAF. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251113604706/en/ TRU Simulation + Training announced delivery and acceptance of the Bell 505 Flight Training Device (FTD) to the Royal Jordanian Air Force (RJAF). “The Bell 505 Flight Training Device provides the Royal Jordanian Air Force a highly advanced training solution that enhances pilot readiness through r

TOURISE Destination Initiative Calls for Global Action for Urban Tourism Safety Through AI13.11.2025 15:42:00 CET | Press release

Launched today at the TOURISE Summit, the TOURISE Destination Initiative (TDI) brings together global leaders from government, international organizations, academia, and the private sector, to transform destinations into living laboratories for tourism innovation. Guided by its Declaration of Principles, TDI champions safety, environmental stewardship, cultural preservation, and community-centered development through responsible technology and multi-sector collaboration. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251113796086/en/ His Excellency Ahmed Al Khateeb, Saudi Arabia's Minister of Tourism and Chairman of TOURISE, launches the TOURISE Destination Initiative, a global coalition to shape the future of tourism through a destination-centric approach, with co-chairs H.R.H. Prince Turki bin Talal bin Abdulaziz Al Saud, Governor of Aseer Province, and Luigi Brugnaro, Mayor of Venice. They are joined with the TDI founding

Twilio’s Latest Report Highlights Conversational AI’s Rapid Adoption, Challenges, and Perception Gaps13.11.2025 15:00:00 CET | Press release

Survey data shows a 31-point satisfaction gap between business leaders’ beliefs and consumers’ experiences with conversational AIWithin the next year, 59% of organizations expect to fully replace the conversational AI solution they have in place todayMore than 70% of consumers claim they can identify an AI agent, but 90% failed to do so correctly Twilio (NYSE: TWLO), the customer engagement platform that drives real-time, personalized experiences for today’s leading brands, today released its Inside the Conversational AI Revolution report.1 Based on a global survey of 457 business leaders and 4,800 consumers across 15 countries, the report unearths major trends related to conversational AI’s adoption, perceptions, and expectations, including a finding that 99% of organizations anticipate their conversational AI strategy will change in the next 12 months. “Businesses that want to successfully deploy conversational AI for customer service, sales, and marketing need to prioritize customer

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