Galderma Group N

Galderma announced new three-year data for Nemluvio in atopic dermatitis and prurigo nodularis at the 2026 Fall Clinical Dermatology Conference in Las Vegas. A post-hoc analysis of the ARCADIA long-term extension study found that of 295 adults and adolescents aged 12 and older who responded at Week 16, 76% achieved clear or almost clear skin and 80% achieved at least a 90% improvement in disease severity at Week 152, with 80% reaching an itch-free or nearly itch-free state. A separate pre-specified interim analysis of the overall ARCADIA LTE population of 1,903 patients showed up to 91% achieved EASI-75 and up to 88% achieved clinically meaningful itch relief at Week 152, with no new safety signals. Phase II pediatric data showed nemolizumab was well tolerated and effective in children aged 2 to 11 with moderate-to-severe atopic dermatitis through Week 52, and a descriptive analysis from the OLYMPIA LTE study showed sustained improvements in prurigo nodularis burden through Week 148. Nemluvio is approved in the United States for adults with prurigo nodularis and patients 12 and older with moderate-to-severe atopic dermatitis, and in more than 40 countries for both adolescents and adults with atopic dermatitis and adults with prurigo nodularis.

Galderma is presenting new three-year data from the ARCADIA long-term extension study showing that Nemluvio, also known as nemolizumab, is well-tolerated and delivers sustained improvements in skin lesions, itch, sleep disturbance and quality of life in adults and adolescents with moderate-to-severe atopic dermatitis. The findings will be shared in an oral presentation at the 2026 European Academy of Dermatology and Venereology Congress in Vienna on Thursday, October 1, by ARCADIA investigator Dr. Matthias Augustin. At Week 152, up to 91% of patients achieved at least 75% improvement in eczema severity, up to 75% achieved at least 90% improvement, up to 67% achieved clear or almost clear skin, up to 88% achieved clinically meaningful itch relief and up to 92% reported clinically meaningful improvements in dermatology-related quality of life, with no new safety signals identified. Lead investigator Professor Jonathan Silverberg of George Washington University School of Medicine and Health Sciences said the improvements were not only achieved but sustained over time, while Galderma global program head Christophe Piketty said the data underscore the company's commitment to addressing patients' long-term needs. Additional EADV 2026 presentations include a post-hoc analysis concluding Nemluvio has a favorable cutaneous safety profile over two years in atopic dermatitis and prurigo nodularis, and analyses identifying clinically meaningful sleep-disturbance improvements linked to itch intensity and skin lesion severity. Nemluvio, the first approved monoclonal antibody targeting IL-31 signaling, was initially developed by Chugai Pharmaceutical and is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis in more than 40 countries.

Galderma has received European Union approval for Restylane Shaype under the Medical Device Regulation for temporary chin augmentation. The product, powered by NASHA HD technology, is described as the firmest hyaluronic acid injectable gel available in the facial filler market. With this decision, Restylane Shaype is now approved in Europe, Canada, and Brazil, making it the first-and-only HA shaper in those regions, according to Baldo Scassellati Sforzolini, Global Head of R&D at Galderma.