ICD 2025: New data demonstrate Nemluvio ® ’s (nemolizumab) favorable safety profile and sustained and clinically meaningful improvements in symptoms of prurigo nodularis up to two years

Galderma (SIX: GALD) today announced data from a new interim analysis of a study investigating the long-term safety and efficacy of Nemluvio in moderate-to-severe prurigo nodularis. The new data show Nemluvio is well tolerated and associated with sustained and clinically meaningful improvements in symptoms including itch and skin lesions, during prolonged treatment up to two years.¹ These new data will be presented as a late-breaking session at ICD, on Saturday, June 21, 2025 at 08:30 AM CET.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250617336479/en/

“These promising data go even further in highlighting the extensive benefits of Nemluvio. As this treatment becomes available in more countries around the world, it’s highly encouraging to see its robust evidence base continue to expand and strengthen.” BALDO SCASSELLATI SFORZOLINI, M.D., PHD. GLOBAL HEAD OF RESEARCH & DEVELOPMENT GALDERMA

Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules, which have a substantial impact on patients’ quality of life.^5-7 Nemluviois the first approved monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31.^8,9,10 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation, skin barrier dysfunction, and fibrosis in prurigo nodularis.^8-11 It is also the first and only biologic approved for prurigo nodularis as well as atopic dermatitis with four-week dosing intervals from the start of treatment.^9,10

The OLYMPIA long-term extension study was designed to assess the safety and efficacy of Nemluvio in patients with prurigo nodularis up to four years and includes 508 patients from the phase II trial or the phase III OLYMPIA 1 and 2 trials.¹ Results show that treatment with Nemluvio is associated with sustained and clinically meaningful improvements in symptoms of prurigo nodularis during prolonged treatment up to two years.¹ At Week 100 in evaluable patients, the interim analysis shows that:

• More than 90% and 70% achieved at least a four-point improvement in itch, and being itch free or nearly itch free respectively, as measured by the Peak-Pruritus Numerical Rating Scale¹
• At least 80% achieved 76‑100% healed pruriginous lesions¹
• Approximately 75% reached clearance or almost-clearance of skin nodules when assessed using the Investigator’s Global Assessment score¹

Nemluvio was well tolerated in the long-term treatment of prurigo nodularis and no new safety signals were identified in this study to date.¹

“These impressive results give us even more confidence in the value of nemolizumab – a much-needed innovative medicine that has the potential to deeply impact the prurigo nodularis treatment landscape. With this new treatment now approved in multiple markets including the EU and U.S., I’m thrilled to be able to see its meaningful impact in the real world.” PROF. SONJA STÄNDER LEAD INVESTIGATOR OF THE OLYMPIA STUDIES IN EUROPE UNIVERSITY HOSPITAL MUNSTER, GERMANY

This follows presentation of results from the ARCADIA long-term extension study at the RAD Conference earlier this month, which showed that treatment with Nemluvio was well tolerated and associated with sustained and increased improvements in symptoms of atopic dermatitis during prolonged treatment up to two years.⁴

Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis.⁹ In December 2024, it was also approved by the U.S. FDA for the treatment of 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.⁹ To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional reviews and submissions are ongoing.

Galderma will also host a symposium at ICD, exploring the latest advances in addressing itch in both prurigo nodularis and atopic dermatitis. Separately, the company will share new data from across its Therapeutic Dermatology portfolio in acne, non-melanoma skin cancer, and rosacea.

More details on Galderma’s scientific presentations at ICD can be found here.

About Nemluvio
Nemluviowas 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.^12,13

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.^5-7 It is an underrecognized and underdiagnosed skin condition, and there are limited studies investigating its prevalence.^11,14,15

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. Ständer S, et a. Nemolizumab long-term efficacy and safety up to 100 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at International Congress of Dermatology; June 18-21, 2025; Rome, Italy.
2. ClinicalTrials.Gov. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501679). Available online. Accessed May 2025
3. ClinicalTrials.Gov. Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501666). Available online. Accessed May 2025
4. Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States.
5. 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
6. 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
7. Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi: 10.1097/itx.0000000000000042
8. 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
9. Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025
10. Nemluvio European Medicines Agency. Summary of Product Characteristics. Available online. Accessed May 2025
11. 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
12. 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 May 2025
13. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025
14. 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
15. Huang AH, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140(2):480-483.e4. doi: 10.1016/j.jid.2019.07.697

View source version on businesswire.com: https://www.businesswire.com/news/home/20250617336479/en/