ICD 2025: New data demo

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

• An interim analysis of the      OLYMPIA long-term extension study to be presented as a late-breaking      abstract at the XIV International Congress of Dermatology (ICD) found that      Nemluvio was well tolerated and associated with sustained and clinically      meaningful improvements in the key signs and symptoms of prurigo      nodularis, including both skin lesions and itch, up to two years¹

• Results build on data from      OLYMPIA – the largest completed pivotal clinical program in prurigo      nodularis and the only one assessing long-term safety and efficacy in      prurigo nodularis^1-3

• This follows the presentation      of data from the ARCADIA long-term extension study at the Revolutionizing      Atopic Dermatitis (RAD) Conference earlier this month, which showed      Nemluvio is well tolerated with sustained and increased improvements in      efficacy outcomes in atopic dermatitis patients up to two years⁴

ZUG, Switzerland -- (BUSINESS WIRE) --

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/

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 Nemluvio is 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

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
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.^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