The U.S. Food and Drug Administration has approved Galderma’s Nemluvio (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older.
The approval is for use in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. Nemluvio is the first approved monoclonal antibody that targets interleukin-31 receptor alpha, which drives itch and is involved in inflammation and epidermal dysregulation in atopic dermatitis.
The approval is based on the results of the Phase III ARCADIA clinical trial program that included 1,728 patients aged 12 years and older with moderate-to-severe atopic dermatitis.
After 16 weeks, patients treated with Nemluvio, administered subcutaneously every four weeks, in combination with TCS (with or without TCI) had statistically significant improvements on skin clearance (either clearance or almost-clearance using the Investigator’s Global Assessment score).
Patients also achieved a 75% reduction in the Eczema Area and Severity Index versus placebo in combination with TCS (with or without TCI), after 16 weeks of treatment.
All key secondary end points were met, including significant responses on itch as early as week one and statistically significant improvements in sleep disturbance. Overall, Nemluvio was well tolerated, with similar safety profiles observed in both the Nemluvio 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,” lead investigator of the ARCADIA trial, Jonathan Silverberg, M.D., Ph.D., from George Washington University in Washington, D.C., said in a statement.
“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.”
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FDA approves Nemluvio for moderate-to-severe atopic dermatitis (2024, December 19)
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