Nemolizumab Receives FDA Approval for Moderate-to-Severe Atopic Dermatitis

The US Food and Drug Administration (FDA) has approved Galderma's Nemluvio (nemolizumab) for patients aged 12 years and older with moderate-to-severe atopic dermatitis. Nemolizumab is to be used in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when topical prescription therapies fail to provide adequate control. This marks nemolizumab as the first monoclonal antibody approved to specifically target IL-31 receptor alpha, a neuroimmune cytokine central to the persistent itch and inflammation characteristic of atopic dermatitis.

The FDA approval is based on findings from the ARCADIA Phase III clinical trial, which assessed nemolizumab’s efficacy and safety in combination with TCS, with or without TCI, in 1,728 patients aged 12 years or older. Results demonstrated that nemolizumab significantly improved skin clearance and itch relief compared to placebo. At week 16, patients receiving nemolizumab achieved statistically significant rates of lesion clearance, and a 75% reduction in the Eczema Area and Severity Index (EASI-75). Additional secondary outcomes highlighted rapid itch relief starting at week 1 and improvements in sleep disturbances; both which are major challenges for atopic dermatitis patients. The safety profile was consistent between nemolizumab and placebo groups.

“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,” stated Professor Jonathan Silverberg, lead investigator of the ARCADIA clinical program. “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.”

This approval follows nemolizumab’s prior FDA approval in August 2024 for prurigo nodularis and adds to its potential as a groundbreaking treatment in dermatology. Flemming Ørnskov, MD, MPH, CEO of Galderma, remarked, “Nemluvio is an important and effective new treatment option for patients with atopic dermatitis, where unmet needs remain.”

Reference

Galderma receives US FDA approval for nemluvio (nemolizumab) for patients with moderate-to-severe atopic dermatitis. Press Release. Galderma. December 14, 2024. Accessed December 16, 2024. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic