FDA Greenlights New Treatment for Moderate-to-Severe Atopic Dermatitis: Daily Dose
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On December 16, 2024, we reported on on the US FDA approval of 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 approval
Nemolizumab is 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.
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.
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. Nemolizumab was well tolerated and displayed a consistent safety profile among the nemolizumab and placebo groups.
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