Galderma and the pan-Canadian Pharmaceutical Alliance (pCPA) successfully complete negotiations for NEMLUVIO® (nemolizumab), for moderate-to-severe atopic dermatitis and prurigo nodularis

• This is another key milestone in offering patients with atopic dermatitis (AD) and prurigo nodularis (PN) access to a novel and effective treatment option.
• Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis, and fibrosis in prurigo nodularis^1,2,3

TORONTO, Sept. 28, 2026 /CNW/ -- Galderma is pleased to announce that it successfully completed negotiations with the pCPA for NEMLUVIO® (nemolizumab for injection), a treatment for patients aged 12 years and older with moderate-to-severe AD, and adult patients with moderate-to-severe PN whose disease is not adequately controlled with topical prescription therapies.

Galderma's focus is on working collaboratively with all stakeholders to help advance access to NEMLUVIO for eligible Canadians. As discussions move forward, the company remains dedicated to the needs of people living with AD and PN and the importance of expanding treatment options for those whose disease is not adequately controlled with existing therapies. This milestone follows the March 2026 Canada's Drug Agency recommendations of "reimburse with conditions" for NEMLUVIO for the treatment of adult and adolescent patients with moderate-to-severe AD and adults with moderate-to-PN. NEMLUVIO also received a positive indication for patients with moderate to serve PN from Institut national d'excellence en santé et en services sociaux (INESSS) in February 2026.

"This announcement brings hope to Canadians living with atopic dermatitis or prurigo nodularis who urgently need new treatment options," said Felicia Glatzel, General Manager, Galderma Canada. "We have appreciated our partnership with the pCPA to achieve this milestone and look forward to collaborating with public drug plans and the dermatology community to help make NEMLUVIO accessible to eligible patients as soon as possible."

"People living with moderate-to-severe atopic dermatitis or prurigo nodularis can experience a significant and ongoing burden from symptoms such as persistent itch, disrupted sleep and skin lesions,^2,4 said Dr. Maxwell Sauder, Assistant Professor, University of Toronto, Dermatologist, Avenue Dermatology Group. "For patients whose disease is not adequately controlled with topical prescription therapies, access to NEMLUVIO is an important option to support patients with the persistent itch, sleep disruption and skin lesions that can substantially affect daily life."

"Both atopic dermatitis and prurigo nodularis can affect far more than the skin, with symptoms often interfering with patients' daily activities, emotional well-being and quality of life,^5,6 said Dr. Chih-ho Hong, Board-Certified Dermatologist, MD, FRCPC. "The completion of pCPA negotiations is an encouraging step toward making another treatment option available Canadian patients living with these challenging chronic inflammatory skin conditions."

About atopic dermatitis and prurigo nodularis

Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.^4,7,8 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.^4,8,9 It affects up to 17% of Canadians at some point in their life.¹⁰ Itch has been reported as the most frequently occurring and most severe symptom of AD. Over 67% of patients reported that itch moderately to severely interfered with heir sleep, and 65% reported that they experience itch without visible rash.¹¹

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.¹²

Prevalence estimates in Canada are limited, but it is estimated to affect 72 per 100,000 people in the United States and 7–111 per 100,000 people in Europe, depending on the country.^13,14 The majority of patients report that the persistent itch negatively impacts their quality of life.¹⁵ Furthermore, the intense itch associated with PN results in significant sleep disturbance and further contributes to reduced quality of life.^16,17

About NEMLUVIO® (nemolizumab for injection)

Atopic Dermatitis

NEMLUVIO (nemolizumab for injection) is indicated for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.¹⁸

Prurigo Nodularis

NEMLUVIO (nemolizumab for injection) is indicated for the treatment of adults with moderate-to severe prurigo nodularis (PN) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.¹⁸

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.  

Safety information

The safety of nemolizumab has been evaluated in clinical trials involving patients with AD and PN. The most common reported adverse reaction in patients with AD included urticaria, a type of hypersensitivity reaction. The most common adverse reactions in patients with PN are headache, dermatitis atopic, eczema and eczema nummular.¹⁸ For complete prescribing information, including contraindications, warnings, and precautions, please consult the NEMLUVIO Product Monograph available through Health Canada.

Forward-looking statements

This press release contains forward-looking statements regarding potential reimbursement and access to NEMLUVIO in Canada. Actual outcomes may differ depending on pCPA negotiations and decisions by public drug plans.

For further information:

Quotes:

"The CDA's recommendation and the completion of pCPA negotiations for NEMLUVIO are encouraging developments for Canadians living with prurigo nodularis," said Dana Gies, Executive Director, Canadian Skin Patient Alliance. "Prurigo nodularis has a profound impact on sleep, mental health, daily functioning and overall quality of life.^1,2,3,4  NEMLUVIO would be the first treatment publicly reimbursed for prurigo nodularis in Canada, this is a significant step toward giving these patients access to another treatment option and greater hope for managing the day-to-day impact of this challenging condition."

"The CDA's positive recommendation and the completion of pCPA negotiations represent meaningful progress for Canadians living with atopic dermatitis," said Amanda Cresswell-Melville, Executive Director, Eczema Society of Canada. "Atopic dermatitis symptoms such as skin inflammation and persistent itch can significantly affect daily life, while these serious conditions can also place a considerable burden on patients, their families and caregivers.^3,4 We are encouraged by this news and look forward to this new treatment being reimbursed on public drug formularies."

References:

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¹ 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. doi:

² Ständer S. Nemolizumab monotherapy improves itch and skin lesions in patients with moderate-to-severe prurigo nodularis: Results from a global phase 3 trial (OLYMPIA 1): Late breaking abstract presented at EADV 2023

³ Kwatra SG, et al. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med. 2023;389: 1579-89. doi: 10.1056/NEJMoa2301333

⁴ 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

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 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

⁷  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

⁸ Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911

⁹ Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi: 10.7861/clinmed.2021-0257

¹⁰ Canadian Dermatology Association. Eczema. Retrieved November 13, 2025 from: https://dermatology.ca/wp-content/uploads/2024/02/Eczema-EN-CDA-Patient-Materials.pdf.  

¹¹ Silverberg JI, et al. Burden of Disease and Unmet Needs in Atopic Dermatitis: Results From a Patient Survey. Dermatitis. 2023 Mar-Apr;34(2):135-144. doi: 10.1089/derm.2022.29015.jsi.

¹² Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi:10.1097/itx.0000000000000042

¹³ 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

¹⁴ Patruno C, et al. Epidemiology and Severity of Prurigo Nodularis in Europe: A Literature Review with an Application to Italian Data. Dermatol Pract Concept. 2025;15(2):4716. doi: 10.5826/dpc.1502a4716.

¹⁵ 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

¹⁶ Pereira MP, Basta S, Moore J, Ständer S. Prurigo nodularis: a physician survey to evaluate current perceptions of its classification, clinical experience and unmet need. J Eur Acad Dermatol Venereol. 2018 Dec;32(12):2224-2229. doi: 10.1111/jdv.15107. Epub 2018 Jul 1. PMID: 29869425; PMCID: PMC6585684

¹⁷ Rodriguez D, et al. Patient Perspectives on Living With Severe Prurigo Nodularis. JAMA Dermatol. 2023;159(11):1205-1212. doi:10.1001/jamadermatol.2023.3251

¹⁸ NEMLUVIO Product Monograph. Galderma Canada Inc

SOURCE Galderma