Ad hoc announcement pursuant to Art. 53 LR
Approximately 7% of people in the United States (U.S.) have atopic dermatitis – a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions1-4
While currently available treatments may improve some signs and symptoms of the disease, many patients do not respond optimally to approved therapies and do not experience itch relief and clear skin to the same degree2,5-7
Nemluvio (nemolizumab) is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31. IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and epidermal dysregulation in atopic dermatitis2,9-11
This approval follows Nemluvio’s recent approval for the treatment of adults with prurigo nodularis from the U.S. Food and Drug Administration earlier in August 202412
ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SWX:GALD) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nemluvio® (nemolizumab) for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. This follows the recent U.S. FDA approval of Nemluvio for subcutaneous injection for the treatment of adults with prurigo nodularis in August 2024.12
Atopic dermatitis affects more than 230 million people worldwide, impacting approximately 7% of people in the U.S.2-4 Often reported as one of patients’ most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians.13-16 Atopic dermatitis is also a highly heterogenous disease and can be associated with several comorbid conditions, namely mental health disorders and other autoimmune- or immune-mediated diseases.2,13,17-19 For this reason, there remains a need for more novel, effective treatment options, as while currently available treatments for atopic dermatitis may improve some signs and symptoms, many patients do not respond optimally to approved therapies and do not experience itch relief and clear skin to the same degree.2,5-7
Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.8 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and epidermal dysregulation in atopic dermatitis.2,9-11
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“As just one example of our innovative, science-based pipeline, Nemluvio is an important and effective new treatment option for patients with atopic dermatitis, where unmet needs remain. Another key milestone on Galderma’s journey, this FDA approval will accelerate the ongoing growth of our U.S. organization and our Therapeutic Dermatology Business, and underscores our commitment to delivering innovative first-in-class solutions to patients across the full spectrum of the fast-growing dermatology market.”
FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA
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