Nemluvio Demonstrates Long-Term Disease Control in Prurigo Nodularis

Zug, Switzerland – February 27, 2026 – Galderma today announced new data from the OLYMPIA open-label extension study investigating the long-term safety and efficacy of Nemluvio® (nemolizumab) in adults with moderate-to-severe prurigo nodularis. The results indicate that Nemluvio maintains long-term disease control and has a well-tolerated safety profile, with clinically meaningful improvements in itch intensity, skin lesions, and quality of life observed for up to three years.¹

First-in-Class Monoclonal Antibody

Nemluvio is the first approved monoclonal antibody specifically designed to target and inhibit the signaling of IL-31, a neuroimmune cytokine that plays a key role in driving itch and other symptoms associated with prurigo nodularis.^2-5 It is currently approved by multiple regulatory authorities worldwide, including the U.S. Food and Drug Administration (FDA) and the European Union (EU), for the treatment of prurigo nodularis and moderate-to-severe atopic dermatitis.^4,5

OLYMPIA LTE Study Results

The interim analysis of the OLYMPIA long-term extension (LTE) study, presented at the 2026 Winter Clinical™ Miami, represents the longest LTE study in prurigo nodularis to date.¹ The study included 508 patients from phase II trials and the OLYMPIA 1 and 2 phase III trials.¹ Key findings include:

• Over 70% of patients achieved clear or almost clear skin lesions based on the Investigator’s Global Assessment score.
• More than 85% of patients experienced a 75% or greater healing of skin lesions based on the prurigo activity score.¹
• Over 85% of patients reported a clinically meaningful improvement in itch, with approximately three-quarters achieving an itch-free or nearly itch-free state.¹
• Approximately 90% of patients demonstrated a clinically meaningful improvement in quality of life, and over 50% reported a Dermatology Life Quality Index score of zero or one, indicating minimal impact of the disease on their daily lives.¹

The long-term safety profile of Nemluvio remained consistent with previous findings.¹

Expert Commentary

“Prurigo nodularis is not only intensely itchy, painful and uncomfortable, it can also take a profound toll on sleep, emotional wellbeing, and daily functioning. That’s why achieving sustained, long-term disease control is critical for patients. These data show that Nemluvio can make a meaningful difference to people’s lives by improving itch, skin lesions and quality of life up to three years, with a well-tolerated safety profile,” said Shawn Kwatra, M.D., Lead Investigator of the OLYMPIA Program and Joseph W. Burnett Endowed Professor and Chairman of Dermatology at the University of Maryland School of Medicine.

Baldo Scassellati Sforzolini, M.D., Ph.D., Global Head of R&D at Galderma, added, “We recognize that prurigo nodularis is a chronic, debilitating condition that patients often struggle with for many years. Our goal has always been to generate robust, long-term evidence on how to ease such disease burden for patients suffering from prurigo nodularis, drawing on data from the largest completed pivotal clinical program and now the longest extension study reported in this disease to date.”

About Prurigo Nodularis

Prurigo nodularis is a chronic, debilitating skin disease characterized by intense itch and the development of thick skin nodules.^10-12 It is estimated to affect between 7-111 people per 100,000 in the EU, and up to 181,000 people in the U.S.^13-16 The persistent itch significantly impacts patients’ quality of life, often leading to sleep disturbance.^17,18

About Galderma

Galderma is a global leader in dermatology, with a presence in approximately 90 countries. The company focuses on delivering innovative, science-based solutions across Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology.^{www.galderma.com}

References

1. Kwatra SG, et al. Nemolizumab long-term safety and efficacy up to 148 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis. Presented at Winter Clinical Miami; February 27- March 1, 2026; Florida, U.S.
2. 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.
3. 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.
4. Nemluvio® U.S. Prescribing Information. Available online. Accessed February 2026.
5. Nemluvio® European Medicines Agency. Summary of Product Characteristics. Available online. Accessed February 2026.
6. ClinicalTrials.Gov. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501679). Available online. Accessed February 2026.
7. ClinicalTrials.Gov. Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501666). Available online. Accessed February 2026.
8. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed February 2026.
9. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed February 2026.
10. Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. Doi: 10.1097/itx.0000000000000042.
11. Huang AH, et al. Prurigo nodularis: Epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. Doi: 10.1016/j.jaad.2020.04.183.
12. Pereira MP, et al. European academy of dermatology and venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. Doi: 10.1111/jdv.14570.
13. Ryczek A, and Reich A. Prevalence of Prurigo Nodularis in Poland. Acta Derm Venereol. 2020;100:adv00155. Doi: 10.2340/00015555-3518.
14. Ständer S, et al. Epidemiology of Prurigo Nodularis compared with Psoriasis in Germany: A Claims Database Analysis. Acta Derm Venereol. 2020;100(18):1-6. Doi: 10.2340/00015555-3655.
15. Kwatra SG, et al. Prevalence of prurigo nodularis in the United States. JAAD Int. 2024;18:134-136. Doi: 10.1016/j.jdin.2023.12.013.
16. Ständer S, et al. Prevalence of prurigo nodularis in the United States of America: A retrospective database analysis. JAAD Int. 2020;2:28-30. Doi: 10.1016/j.jdin.2020.10.009.
17. Todberg T, et al. Treatment and Burden of Disease in a Cohort of Patients with Prurigo Nodularis: A Survey-based Study. Acta Derm Venereol. 2020;100(8):adv00119. Doi: 10.2340/00015555-3471.
18. Kwatra SG. Breaking the Itch–Scratch Cycle in Prurigo Nodularis. N Engl J Med. 2020;382(8):757-758. Doi: 10.1056/NEJMe1916733.
19. Aggarwal P, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46(7):1277-1284. Doi: 10.1111/ced.14722.