The US Food and Drug Administration (FDA) has approved Galderma‘s monoclonal antibody, Nemluvio (nemolizumab), for individuals aged 12 years and over with moderate-to-severe atopic dermatitis.
The new therapeutic option is to be used in conjunction with topical corticosteroids and/or calcineurin inhibitors when the condition is inadequately controlled by topical prescription therapies.
The FDA’s decision was supported by positive findings from the Phase III clinical trial programme, ARCADIA, involving 1,728 subjects aged 12 years or above with moderate-to-severe atopic dermatitis. The findings showed that the combination therapy significantly improved skin clearance versus placebo.
Galderma CEO FLEMMING ØRNSKOV stated: “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 US organisation 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.”
This approval follows the FDA’s previous approval of Nemluvio via subcutaneous injection to treat adults with prurigo nodularis in August 2024.
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In Europe, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has also adopted a positive opinion, recommending the therapy’s approval for atopic dermatitis and prurigo nodularis.
The European Commission will review this recommendation for potential approval across the EU and additional countries.
Galderma is seeking marketing authorisation for the therapy in various regions. Applications are under review by regulatory authorities in Australia, Brazil, Canada, Singapore, South Korea and Switzerland through the access consortium framework, and other submissions are planned for 2025.
Initially developed by Chugai Pharmaceutical, Nemluvio’s rights for development and marketing were acquired by Galderma in 2016, excluding Japan and Taiwan.
Marketed as Mitchga in Japan it is approved for prurigo nodularis and associated pruritus.
