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

Access Advance Announces New Effective Discount Rates for Its Multi-Codec Bridging Agreement, Starting on January 1, 202711.11.2026 20:18:00 CET | Press release

Access Advance LLC today announced that the Licensors of the HEVC Advance and VVC Advance Patent Pools have independently approved a two-step, phased reduction in the effective royalty discount available under the Multi-Codec Bridging Agreement (MCBA) for Licensees of both pools who sign the MCBA on or after January 1, 2027. Licensees that join both the HEVC Advance and VVC Advance Patent Pools and execute the MCBA on or before December 31, 2026, will secure the current MCBA rates, resulting in an effective discount of up to 50%. Licensees that sign on or after January 1, 2027 will receive a reduced discount as further described below. The MCBA is an administrative agreement, not a separate license, that lets Licensees of both HEVC Advance and VVC Advance Patent Pools pay a single, reduced royalty rate for products that include both HEVC and VVC codecs. Today the MCBA rate for a dual-codec product is the same as the VVC Advance single codec product rate; up to 50% of what a Licensee wo

Angel Aligner Unveils Six Innovations for 202711.11.2026 17:23:00 CET | Press release

Angel Elevates the Orthodontic Specialty by Focusing on Complex-Case Solutions Angelalign Technology Inc. (6699.HK) (“Angel”), a global clear aligner leader, has unveiled six new clinical innovations, including SuperElastic (MC-SE)* aligner material, a Deepbite Solution for significantly expanded indications, and the Adapt-MATMsystem for next generation growth guidance for young patients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261110338654/en/ Unveiling Angel's 2027 Innovations. Orthodontists and opinion leaders have long remarked about Angel’s clinical excellence. Orthodontics educator and thought leader Dr. David Sarver said: “In over 4 decades, I’ve never had a parent say I’d be happy if you ensure that my child’s treatment results are average.” Angel is committed to elevating the orthodontic specialty well above the average, especially as more competition and harder referral cases demand outstanding results. Bind

Abu Dhabi Future Health Summit Concludes with Research Partnerships and New Programmes to Advance Prevention and Health Innovation11.11.2026 15:58:00 CET | Press release

Partnerships span drug discovery, clinical research, preventive and reproductive health Launch of an AI Clinician Framework and a Trusted Research Environment for health and genomic data Four whitepapers address genomics, therapeutics, fertility and wearable technologies New programmes support health innovators and entrepreneurs More than 17,300 visitors from 85 countries, with 130 speakers across 45 sessions Held under the patronage of His Highness Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Chairman of the Abu Dhabi Executive Council, Abu Dhabi Future Health Summit 2026 concluded with agreements and initiatives spanning drug discovery, clinical research, preventive and reproductive health, alongside research and entrepreneurship programmes that will sustain collaboration beyond the Summit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261111545964/en/ The Summit is the annual flagship gath

De' Longhi Group: Record Results for the Quarter, With Revenue Growing by 7.7% and Net Profit Pertaining to the Group Progressing Significantly by 19%11.11.2026 15:58:00 CET | Press release

The Board of Directors of De' Longhi S.p.A. approved the consolidated results1 for the nine months of 2026. In the nine months the Group achieved: revenues for € 2,621.3 million, up by 6.5% with respect to 2025 (+7.7% at constant currency); an adjusted2 Ebitda of € 455.2 million, equal to 17.4% on revenues (vs. 15.8% with respect to last year); a net income pertaining to the Group equal to € 225.8 million (+20.4% with respect to last year); a positive net financial position equal to € 606.0 million. CEO Fabio de' Longhi commented: “The Group delivered its thirteenth consecutive quarter of organic revenue growth, underscoring our proven ability to capitalize on industry opportunities and respond promptly to market evolution, while ensuring consistent performance across both divisions. The professional business recorded a strong acceleration, spanning all geographies and brands, with revenues growth exceeding 35% for both the quarter and the nine-month period, this against an already par

Starr Chile Assigned A Rating from AM Best11.11.2026 14:30:00 CET | Press release

Starr, a global insurance and investment organization, today announced that the global credit rating agency AM Best has assigned Starr International Seguros Generales S.A. (Starr Chile) a Financial Strength Rating of A (Excellent) and a Long-Term Issuer Credit Rating of a+ (Excellent). The outlook for both credit ratings is positive. The rating reflects Starr’s strong balance sheet and Starr Chile’s successful implementation of Starr’s business model. AM Best also cited Starr’s operating performance, a favorable business profile and enterprise risk management as key factors supporting the positive rating. “This strong rating is another important endorsement of Starr’s business model as we continue to build our presence in Latin America,” said Jeff Greenberg, chairman and co-CEO of Starr. “It reflects the financial strength, underwriting discipline and experienced teams that underpin our business around the world, reinforcing the confidence brokers and clients can place in Starr.” Starr

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