Galderma’s Nemluvio Secures Dual EU Approvals for Atopic Dermatitis and Prurigo Nodularis

The European Commission has approved Galderma's Nemluvio (nemolizumab) for both moderate-to-severe atopic dermatitis and prurigo nodularis1 3.

Nemluvio is approved for subcutaneous use in patients aged 12 years and older with moderate-to-severe atopic dermatitis who are candidates for systemic therapy4.

It is also approved for subcutaneous use in adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy4.

Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives itch and is involved in inflammation and skin barrier dysfunction4 5.

The approval is based on results from the phase III ARCADIA and OLYMPIA clinical trial programs, which demonstrated significant improvements in itch, skin lesions, and sleep disturbance1 3.

Nemluvio is the first monoclonal antibody in Galderma's portfolio of innovative, science-based products1.

The drug was previously approved by the FDA in December 2024 for atopic dermatitis and in August 2024 for prurigo nodularis2 5.

Atopic dermatitis affects approximately 230 million people worldwide, including 7% of the United States population2.

Nemluvio is administered subcutaneously every four weeks, making it the first and only biologic approved for atopic dermatitis and prurigo nodularis with this dosing schedule from the start of treatment1.