Galderma’s Nemluvio ® (nemolizumab) Demonstrates Long-Term Disease Control in Prurigo Nodularis up to Three Years

Galderma (SIX: GALD) today announced new data from the OLYMPIA open-label extension study investigating the long-term safety and efficacy of Nemluvio in moderate-to-severe prurigo nodularis.¹ Results showed that Nemluvio maintained long-term disease control and a well-tolerated safety profile, with clinically meaningful improvements in itch intensity, skin lesions and quality of life up to three years.¹ Results will be presented at 2026 Winter Clinical Miami and build on previous data from OLYMPIA – the largest completed pivotal clinical program in prurigo nodularis and the only one with a LTE study.^1,6,7

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“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.” DOCTOR SHAWN KWATRA, M.D. LEAD INVESTIGATOR OF OLYMPIA PROGRAM JOSEPH W. BURNETT ENDOWED PROFESSOR AND CHAIRMAN OF DERMATOLOGY UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE

Nemluvio demonstrated long-term improvements in itch intensity, skin lesions and quality of life
The OLYMPIA LTE study was designed to assess the safety and efficacy of Nemluvio in patients with prurigo nodularis up to four years and included 508 patients from the phase II trial and the OLYMPIA 1 and 2 phase III trials.¹ At Week 148, in evaluable patients, the interim analysis showed that Nemluvio maintained long-term disease control with a consistent safety profile:

• Over 70% of patients achieved clear or almost clear skin lesions based on Investigator’s Global Assessment score, and over 85% achieved more than 75% of healed lesions based on prurigo activity score.¹
• Over 85% of patients achieved a clinically meaningful itch improvement, and about three-quarters attained an itch-free or nearly itch-free state.¹
• About 90% of patients achieved a clinically meaningful improvement in quality of life, and >50% achieved a Dermatology Life Quality Index score of zero or one, meaning no effect of the disease on quality of life.¹
• The long-term safety profile of Nemluvio remained consistent with previous findings and aligned with previously established safety data for prurigo nodularis.¹

“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.” BALDO SCASSELLATI SFORZOLINI, M.D., PH.D. GLOBAL HEAD OF R&D GALDERMA

Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.^2-5 IL-31 is a neuroimmune cytokine that drives itch and other symptoms in prurigo nodularis.^2-5 Nemluvio is approved by multiple regulatory authorities around the world for the treatment of prurigo nodularis and moderate-to-severe atopic dermatitis, including in the U.S. and EU.^4,5

Media can find more information and resources on prurigo nodularis in this toolkit.

About Nemluvio
Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga^® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.^8,9

Nemluvio was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with prurigo nodularis, and patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.⁴ To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including in the EU, Australia, Singapore, Switzerland and the United Kingdom. Additional regulatory submissions and reviews are ongoing.

About prurigo nodularis
Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.^10-12 It is estimated to affect between 7-111 people per 100,000 in the EU depending on the country and up to 181,000 people in the U.S.^13-16 The majority of patients report that the persistent itch negatively impacts their quality of life.¹⁷ Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life.^18,19

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. 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.

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