GALDERMA LAUNCHES "SCRATCH RESISTANCE" CAMPAIGN TO VALIDATE THE PHYSICAL AND EMOTIONAL BURDENS OF ATOPIC DERMATITIS

"Itch is the most common symptom of atopic dermatitis, but the impact of itch is often more than skin deep. Unrelenting itch can have a significant emotional burden, with patients experiencing anxiety, sleep disturbance, frustration, and in severe cases, depression. With the launch of 'Scratch Resistance,' we hope to bridge the gap between the physical and emotional symptoms of atopic dermatitis and help patients get back to feeling like themselves faster with NEMLUVIO. This campaign underscores our commitment to innovation in dermatology and our dedication to improving the quality of life for those living with atopic dermatitis."

DEBRA HAGAN
VICE PRESIDENT, GENERAL MANAGER AND HEAD OF U.S. THERAPEUTIC DERMATOLOGY
GALDERMA

Atopic dermatitis impacts approximately 26.1 million people in the U.S. each year and often feels like a relentless cycle of itch which can negatively impact sleep, engagement at work or school, confidence, and the ability to enjoy daily activities.^2-3 While treatment options for atopic dermatitis are available, many patients remain frustrated and disappointed with the limitations of these options, with 87% of patients seeking freedom from persistent itch.^2,4-8

The unrelenting itch of atopic dermatitis can make patients resourceful, leading them to scratch with just about anything. Galderma's "Scratch Resistance" campaign is designed to validate this experience by highlighting different objects people with atopic dermatitis use to scratch their itch and show them that with NEMLUVIO, you can get over your eczema itch and whatever you use to scratch it.¹ 

"Scratch Resistance" will live across broadcast TV channels and will also be featured on consumer-facing platforms across Facebook, Instagram, digital banner ads, and more.

For more information, visit www.NEMLUVIO.com. 

NEMLUVIO is the first and only treatment that helps stop IL-31 signaling, a key driver of the itch, scratching, inflammation, and rash of atopic dermatitis.^1,9-12 This unique approach addresses the root causes of atopic dermatitis symptoms and delivers rapid itch relief, starting in as little as 48 hours.^1,9-14* By relieving itch and reducing the urge to scratch, NEMLUVIO allows skin to clear.^1,9-10

Following the U.S. FDA approval of NEMLUVIO for the treatment of adults with prurigo nodularis (PN) in August 2024, NEMLUVIO was approved in December 2024 for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies.¹⁵ With NEMLUVIO, Galderma continues to lead in dermatological innovation, providing hope and much needed relief to countless individuals affected by atopic dermatitis and prurigo nodularis.

About NEMLUVIO^® (Nemolizumab-ilto)
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 and Taiwan. 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.^16,17 NEMLUVIO has been approved by the European Commission for both moderate-to-severe atopic dermatitis and moderate-to-severe prurigo nodularis in the European Union (EU).¹⁸ It is now approved in the EU for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.¹⁸ The U.S. FDA has also approved NEMLUVIO 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 (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies.¹⁵ NEMLUVIO is also under review for the treatment of both diseases by several additional regulatory authorities around the world. Further submissions to regulatory authorities in additional countries are ongoing.

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.

For further information:

References
*At 16 weeks, many saw significant itch improvement. In a follow-up analysis, results were observed as soon as 48 hours. Individual results may vary.

1. NEMLUVIO (nemolizumab-ilto) injection for Atopic Dermatitis Prescribing Information. Dallas, TX: Galderma Laboratories, L.P. 12/2024.
2. National Eczema Association. Atopic dermatitis. Accessed October 29, 2024. https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/.
3. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Atopic dermatitis. Accessed October 24, 2024. https://www.niams.nih.gov/health-topics/atopic-dermatitis.
4. Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360.
5. Lobefaro F, et al. Atopic Dermatitis: Clinical Aspects and Unmet Needs. Biomedicines. 2022;10:2927.
6. Katoh N, Ohya Y, Ikeda M, et al. Clinical practice guidelines for the management of atopic dermatitis 2018. J Dermatol. 2019;46(12): 1053-1101.
7. 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.
8. Augustin M, Costanzo A, Pink A, 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;102:adv00830.
9. Nemmer JM, Kuchner M, Datsi A, et al. Interleukin-31 signaling bridges the gap between immune cells, the nervous system and epithelial tissues. Front Med (Lausanne). 2021;8:639097.
10. DUPIXENT Prescribing Information. Sanofi and Regeneron Pharmaceuticals, Inc. 2024.
11. ADBRY Prescribing Information. Leo Pharma, Inc. 2024.
12. EBGLYSS Prescribing Information. Eli Lilly and Company. 2024.
13. Silverberg J, Stein-Gold L, Thaçi D, et al. Nemolizumab elicits rapid itch response in atopic dermatitis within 2 days: a post hoc analysis of ARCADIA 1 and 2 data. Presented at: Revolutionizing Atopic Dermatitis Conference; June 8-10, 2024; Chicago, IL.
14. Morrow T, Felcone LH. Defining the difference: what makes biologics unique. Biotechnol Healthc. 2004;1(4):24-29.
15. NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.; August 2024.
16. 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 2025.
17. ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03985943). Available online. Accessed February 2025.
18. Nemluvio. EU Summary of Product Characteristics 2025.

SOURCE Galderma