Nemolizumab Granted FDA Approval For Moderate-to-Severe Atopic Dermatitis

The FDA has approved nemolizumab (Nemluvio; Galderma) for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCIs) when the disease is not controlled by topical prescription therapies among individuals 12 years and older.¹

Image credit: Ольга Тернавская | stock.adobe.com

The approval marks nemolizumab as the first FDA-approved monoclonal antibody that exclusively targets IL-31 receptor alpha, inhibiting the signaling of IL-31 — a neuroimmune cytokine that initiates itch and inflammation in atopic dermatitis.¹ The approval follows the August 2024 FDA approval of nemolizumab as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.^2,3

“Nemluvio is an important and effective new treatment option for patients with atopic dermatitis, where unmet needs remain,” said Flemming Ornskov, MD, MPH, Galderma’s chief executive officer.¹

Atopic dermatitis impacts more than 230 million individuals globally, affecting 7% of individuals in the US. The flaring inflammatory skin disease is common and chronic, often presenting as skin lesions which are recurrent and cause a persistent itch in 87% of patients. Symptoms of atopic dermatitis include dry cracked skin, itchiness, rash on swollen skin, small raised bumps, oozing and crusting, thickened skin, darkening of the skin around the eye, and raw sensitive skin from scratching.⁴

Additionally, atopic dermatitis is a heterogenous disease that is linked with several comorbid conditions, including health disorders and autoimmune- or immune-mediated diseases, emphasizing the need for further effective treatment options.¹

The approval was granted based on positive results from the phase 3 ARCADIA clinical trial program that assessed the efficacy and safety of nemolizumab in combination with background TCS, with or without TCI, compared with placebo in combination with TCS with or without TCI. The trial included 1728 individuals with moderate-to-severe atopic dermatitis aged 12 years or older.¹

The study authors noted that the results demonstrated statistically significant improvements in skin clearance among individuals treated with nemolizumab in combination with TCS, with or without TCI. Skin clearance was categorized as clearance (0) or almost-clearance (1) of skin lesions, which were assessed using the investigator’s global assessment score. Further results displayed that nemolizumab achieved a 75% reduction in the Eczema Area and Severity Index after 16 weeks of treatment, compared to placebo with TCS, with or without TCI.¹

The clinical trial met its co-primary end points of skin clearance, along with all key secondary end points of significant itch response starting week 1 with treatment, and improvements in sleep disturbance in individuals treated with nemolizumab compared to placebo.¹

“Despite currently available treatment options, atopic dermatitis continues to have a massive impact worldwide, with patients not only burdened by intense itch and recurrent skin lesions, but also potentially several associated symptoms including sleep issues, pain, anxiety, and depression,” said lead study investigator, Johnathan Silverberg, professor of dermatology at George Washington University School of Medicine and Health Sciences. “I look forward to being able to offer this option to atopic dermatitis patients in my practice who are seeking relief from burdensome itch and lesions.”¹

Nemolizumab was tell tolerated and displayed a consistent safety profile among the nemolizumab and placebo groups, according to study authors.¹

REFERERNCES

1. Galderma Receives U.S. FDA Approval for Nemluvio® (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis. Galderma. News release. December 14, 2024. Accessed December 16, 2024. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic.

2. Galderma receives U.S. FDA approval for Nemluvio® (nemolizumab) for adult patients living with prurigo nodularis. Galderma. News release. August 13, 2024. Accessed December 16, 2024. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo.

3. Halpern L. Nemolizumab Granted FDA Approval For Adults Living With Prurigo Nodularis. Pharmacy Times. News release. August 13, 2024. Accessed December 16, 2024. https://www.pharmacytimes.com/view/nemolizumab-granted-fda-approval-for-adults-living-with-prurigo-nodularis.

4. Atopic dermatitis (eczema). Mayo Clinic. News release. May 15, 2024. Accessed December 16, 2024. https://www.mayoclinic.org/diseases-conditions/atopic-dermatitis-eczema/symptoms-causes/syc-20353273.