RAD 2025: Long-Term Data

RAD 2025: Long-Term Data on Nemluvio® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years

• New interim two-year data      from a long-term extension study of Nemluvio in atopic      dermatitis reinforce its rapid onset of action and demonstrate its lasting      impact across multiple clinical and patient reported outcomes including      itch and skin lesions¹

• Results build on data from      the phase III ARCADIA program, showing Nemluvio’s consistent safety      profile and sustained and increased improvements in efficacy outcomes in      atopic dermatitis patients during prolonged treatment up to two years^1,2

• Two-year data from a      long-term extension study of Nemluvio in prurigo nodularis will also be      presented later in June at the International Congress of Dermatology

ZUG, Switzerland -- (BUSINESS WIRE) --

Galderma (SIX: GALD) today announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio in moderate-to-severe atopic dermatitis. The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years.¹ These data will be presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference, taking place from June 6-7, 2025.

Atopic dermatitis affects more than 230 million people worldwide.³ Often reported as one of patients’ most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians.^4-7 Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.^3,8,9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis.^8,10 Nemluvio is also the first and only biologic approved for atopic dermatitis as well as prurigo nodularis with four-week dosing intervals from the start of treatment, and the only option to move to eight-week dosing intervals for appropriate patients with atopic dermatitis.⁹

The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe atopic dermatitis up to five years and includes more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients.¹

Results to be presented at the RAD Conference will show that Nemluvio is associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years.¹ At week 104 in evaluable patients, the interim analysis shows that:

• More than 85% achieved a 75%      reduction in the Eczema Area and Severity Index (EASI)¹

• Approximately 85% and 70%      achieved an at least four-point improvement in itch, and being itch free      or nearly itch free, respectively, when assessed using the SCORing Atopic      Dermatitis (SCORAD) Visual Analog Scale (VAS) Pruritus score. Improvements      in sleep mirrored those in itch¹

• Approximately 60% reached      clearance or almost-clearance of skin lesions when assessed using the      Investigator’s Global Assessment (IGA) score¹

• Patients’ quality of life      improved over time, as measured by the Dermatology Life Quality Index      (DLQI)¹

Results also reinforce Nemluvio’s rapid onset of action on itch and skin at Week 4, with 49% of patients who entered the long-term extension study naïve to Nemluvio achieving a 75% reduction in the EASI, and 69% achieving an at least four-point improvement in itch when assessed using the SCORAD VAS Pruritus score.¹

Nemluvio was well tolerated in the long-term treatment of atopic dermatitis and no new safety signals were identified.¹

Additional data from both the ARCADIA program in atopic dermatitis, as well as from the OLYMPIA open-label extension study in prurigo nodularis will be presented at RAD 2025, reinforcing Nemluvio’s rapid impact on key symptoms of atopic dermatitis, and its long-term efficacy in prurigo nodularis.^11,12

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 regulatory submissions and reviews are ongoing.

More details on Galderma’s scientific presentations at RAD 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.^13,14

About atopic dermatitis
Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.^3,15,16 It affects more than 230 million people worldwide.³ It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.¹⁷

Important Safety Information
Indications: NEMLUVIO^® (nemolizumab-ilto) is a prescription medicine used:

• to treat adults and children      12 years of age and older with moderate-to-severe eczema (atopic      dermatitis or AD) in combination with prescription therapies used on the      skin (topical) when the eczema is not well controlled by topical therapies      alone. It is not known if NEMLUVIO is safe and effective in children with      atopic dermatitis under 12 years of age.

• to treat adults with prurigo      nodularis. It is not known if NEMLUVIO is safe and effective in children      with prurigo nodularis under 18 years of age.

Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you:

• are scheduled to receive any      vaccination. You should not receive a live vaccine right before or during      treatment with NEMLUVIO.

• are pregnant or plan to      become pregnant. It is not known whether NEMLUVIO will harm your unborn      baby.

• are breastfeeding or plan to      breastfeed. It is not known whether NEMLUVIO passes into your breast milk      and if it can harm your baby.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

• Breathing problems or      wheezing

• Swelling of the face, lips,      mouth, tongue, or throat

• Fainting, dizziness, feeling      lightheaded

• Fast pulse

• Swollen lymph nodes

• Joint pain

• Fever

• Skin rash (red or rough skin)

• Nausea or vomiting

• General ill feeling

• Cramps in your stomach area

The most common side effects of NEMLUVIO include:

• Eczema: headache,      joint pain, hives (itchy red rash or wheals), and muscle aches

• Prurigo Nodularis:      headache and skin rashes: atopic dermatitis (a type of eczema), eczema,      and eczema nummular (scattered circular patches)

These are not all of the possible side effects of NEMLUVIO.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088.

Please see full Prescribing Information including Patient Information.

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. 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.

2. 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

3. 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

4. Silverberg JI, et al. Patient      burden and quality of life in atopic dermatitis in US adults: a      population-based cross-sectional study. Ann Allergy Asthma Immunol.      2018;121(3):340-347. doi: 10.1016/j.anai.2018.07.006

5. 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

6. Durno N, et al. Biologics and      oral systemic treatment preferences in patients and physicians for      moderate-to-severe atopic dermatitis: a discrete choice experiment in the      United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi:      10.1080/09546634.2024.2417966

7. Penton H, et al. Assessing      Response in Atopic Dermatitis: A Systematic Review of the Psychometric      Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther      (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3

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. 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

11. Silverberg JI, et al.      Nemolizumab was associated with rapid and significant improvements in itch      and sleep in patients with moderate-to-severe atopic dermatitis: Results      from two global phase 3 pivotal studies (ARCADIA 1 and ARCADIA 2).      Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7;      Nashville, United States.

12. Yosipovitch G, et al.      Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA      open-label extension study in patients with prurigo nodularis: An interim      analysis. Presented at Revolutionizing Atopic Dermatitis Conference 2025;      June 6-7; Nashville, United States.

13. 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

14. 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

15. Ständer S. Atopic dermatitis.      N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911

16. Yang G, et al. Skin Barrier      Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol      Sci. 2020;21(8):2867. doi: https://doi.org/10.3390/ijms21082867

17. Raharja A, et al. Psoriasis:      a brief overview. Clin Med (Lond). 2021;21(3):170-173.      doi:10.7861/clinmed.2021-0257