FDA Approves Nemolizumab for Treatment of Moderate-to-Severe Atopic Dermatitis

The US FDA approved nemolizumab (Nemluvio; Galderma) for the treatment of patients aged 12 years and older with 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.

The December 13, 2024, 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, according to a press release from Galderma.

In August 2024, the FDA approved nemolizumab as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis, according to Galderma.

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

The approval was 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 study included 1728 individuals aged 12 years and older with moderate-to-severe atopic dermatitis.

According to the results, participants who received nemolizumab—administered subcutaneously for 4 weeks in combination with TCS, with or without TCI—showed statistically significant improvements on skin clearance in both coprimary endpoints. These endpoints were clearance (0) or almost-clearance (1) of skin lesions that were assessed using the investigator’s global assessment score and achieving a 75% reduction in the Eczema Area and Severity Index (EASI) after 16 weeks of treatment, compared to placebo with TCS, with or without TCI.

Also, the studies met all key secondary endpoints confirming significant responses on itch as early as week 1, and statistically significant improvements in sleep disturbance with nemolizumab in patients treated with nemolizumab compared to placebo, according to the release.

Nemolizumab was well tolerated and displayed a consistent safety profile among the nemolizumab and placebo groups, according to Galderma.

“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,” lead ARCADIA investigator, Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at George Washington University School of Medicine and Health Sciences, said in the release. 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.”

Reference: Galderma receives U.S. FDA approval for Nemluvio® (nemolizumab) for patients with moderate-to-severe atopic dermatitis. News release. Galderma. December 13, 2024. Accessed December 16, 2024. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic