Ad hoc announcement pursuant to Art. 53 LR
This approval from the European Commission is based on robust results from the phase III OLYMPIA and ARCADIA clinical trial programs, showing that Nemluvio has the potential to address the significant unmet needs of patients with atopic dermatitis and prurigo nodularis1-3
There is a need for new treatment options for atopic dermatitis and prurigo nodularis to effectively relieve the signs and symptoms such as persistent itch, skin lesions and poor sleep quality4-8
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 dysfunction in both atopic dermatitis and prurigo nodularis, and fibrosis in prurigo nodularis5,8-10
Nemluvio is the first monoclonal antibody in Galderma’s portfolio of innovative, science-based products, which span the full spectrum of the fast-growing dermatology market
ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SWX:GALD) today announced that the European Commission has approved Nemluvio for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio is now approved for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.11
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“Throughout Galderma’s four decades in dermatology we have consistently worked to meet the needs of patients and deliver first-in-class treatment options. This has been exemplified through the clinical and regulatory success achieved with our unique monoclonal antibody, Nemluvio. As the first biologic treatment in our Therapeutic Dermatology portfolio, Nemluvio shows our commitment to advancing dermatology by expanding into new areas of need.”
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