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Approval Alert: European Commission Approves Galderma’s Nemolizumab

Feb 14, 2025

On 14 February 2025, Galderma announced that the European Commission has approved Nemluvio® (nemolizumab) for both moderate to severe atopic dermatitis and prurigo nodularis.

According to Galderma, Nemluvio® is the first approved mAb specifically targeting IL-31 receptor alpha, inhibiting the signalling of IL-31 (which drives itch and is involved in inflammation and skin barrier dysfunction), and the only approved biologic for atopic dermatitis and prurigo nodularis with 4-week dosing intervals from the start of treatment.

Nemluvio® received a positive opinion from the EMA’s CHMP in December 2024.