Galderma announces the authorization of NEMLUVIO® (nemolizumab) for atopic dermatitis and prurigo nodularis in Canada

• NEMLUVIO is the first authorized monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.¹ IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis ^2-5
• NEMLUVIO is now authorized for sale by Health Canada based on results from the phase III ARCADIA and OLYMPIA clinical trial programs, which showed that NEMLUVIO significantly improved itch, skin lesions and sleep disturbance in atopic dermatitis and prurigo nodularis ^6-8
• Atopic dermatitis, a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions, impacts up to 17% of Canadians at some point in their life^{2, 9-11}
• Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by intense itch and thick skin nodules covering large body areas, with a prevalence that may range from 7–111 people per 100,000^12-15

THORNHILL, ON, Jan. 12, 2026 /CNW/ - Galderma Canada has announced the Health Canada authorization of NEMLUVIO (nemolizumab), a first-in-class biologic treatment for both moderate-to-severe atopic dermatitis and prurigo nodularis. NEMLUVIO was granted authorization for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Furthermore, NEMLUVIO was granted authorization for the treatment of adults with moderate-to-severe prurigo nodularis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.¹

"Building on its longstanding dermatology heritage, Galderma introduces the first monoclonal antibody targeting IL-31 receptor alpha for Canadians suffering from atopic dermatitis and prurigo nodularis", said Sophie Élise Michaud, Ph.D., Head Medical Affairs, Galderma Canada Inc. "NEMLUVIO represents an important advancement that addresses a significant unmet medical need and helps alleviate the substantial disease burden faced by patients with either condition."

The authorization for sale was based on robust results from the phase III ARCADIA and OLYMPIA clinical trial programs in atopic dermatitis and prurigo nodularis, respectively.

The phase III ARCADIA 1 and ARCADIA 2 trials met their co-primary endpoints and all key secondary endpoints, demonstrating that NEMLUVIO, administered subcutaneously every four weeks in combination with background topical corticosteroids or topical calcineurin inhibitors (+TCS/TCI), clinically improved skin lesions, and significantly improved itch and sleep disturbance in patients aged 12 years and older with moderate-to-severe atopic dermatitis, when compared to placebo +TCS/TCI.⁶ Significant itch relief was observed as early as Week 1.⁶

Results from the phase III OLYMPIA 1 and OLYMPIA 2 trials showed that NEMLUVIO monotherapy met all primary and key secondary endpoints and demonstrated significant and clinically meaningful improvements on itch, skin lesions and sleep disturbance in adult patients with prurigo nodularis, compared to placebo.^7,8 Reduction in itch due to prurigo nodularis was observed as early as Week 4.^7,8

"For people living with atopic dermatitis or prurigo nodularis, itch is more than a symptom – it's often the most disruptive part of their daily lives", said Dr. Chih-ho Hong, Board-Certified Dermatologist, MD, FRCPC, Surrey, BC. "Nemolizumab's ability to rapidly target itch makes it an exciting and much-needed advancement, offering patients relief where they need it most."

Atopic dermatitis and prurigo nodularis are both skin conditions driven by neuroimmune dysfunction, which manifests as itch (pruritus), inflammation, and skin barrier dysfunction in atopic dermatitis, and itch, inflammation, altered epidermal differentiation and fibrosis (thickening or scarring of skin tissue causing firm bumps) in prurigo nodularis.^2,16

In both conditions, itch is often reported as one of patients' most problematic symptoms, with 87% of atopic dermatitis patients saying that they are seeking freedom from itch, and 75% of prurigo nodularis patients reporting that persistent itch negatively impacts their quality of life.^17,18 Aside from chronic itch, patients can develop mental health disorders and suffer a psychosocial burden from developing skin nodules, which can be on visible areas of the body and significantly impact confidence and social interactions.^12,14,19,20 Scratched nodules can also bleed, increasing the risk of recurrent infections that cause additional burden.²¹

Given the significant burden that these serious diseases place on patients, their families, and caregivers,^14,19 the authorization for sale of NEMLUVIO helps to address the need for new treatment options in Canada that can effectively relieve the signs and symptoms.

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 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.^22,23 

About the ARCADIA clinical trial program⁶

The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2. 

These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered in combination with background topical corticosteroids or topical calcineurin inhibitors).⁶

The trials were conducted in adolescent and adult patients (12 years and over) with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks.⁶ Patients who responded to treatment (defined as patients who achieved an investigator's global assessment score of clear (0) or almost clear (1), or a 75% or greater improvement in the eczema area and severity index score) were then re-randomized to a maintenance treatment phase for up to 48 weeks.⁶

About atopic dermatitis

Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.^2,9,10 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.^2,10,24 It affects up to 17% of Canadians at some point in their life.¹¹ Itch has been reported as the most frequently occurring and most severe symptom of atopic dermatitis.  Over 67% of patients reported that itch moderately to severely interfered with heir sleep, and 65% reported that they experience itch without visible rash.²⁵

About the OLYMPIA clinical trial program^7,8

The OLYMPIA program included two identically designed, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest completed pivotal clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study. 

These global, randomized, double-blind, placebo-controlled phase III clinical trials assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with moderate-to-severe prurigo nodularis over a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively. 

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.¹⁴

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.^12,15 The majority of patients report that the persistent itch negatively impacts their quality of life.¹⁸ Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life.^13,20

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:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com

+41 76 315 26 50

Céline Buguet

Franchises and R&D Communications Director

celine.buguet@galderma.com

+41 76 249 90 87

References:

SOURCE Galderma