Galderma announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio in moderate-to-severe atopic dermatitis. The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years. These data will be presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference, taking place from June 6-7, 2025.

The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of NemluVio in patients with moderate-to-severe atopopic dermatitis up to five years and includes more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients. Results to be presented at the RAD Conference will show that Nemluvio are associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years; At week 104 in evaluable patients, the interim analysis shows that: More than 85% achieved a 75% reduction in the Eczema Area and Severity Index (EASI); Approximately 85% and 70% achieved an at least four-point improvement in itch, and being itch free or nearlyitch free, respectively, when assessed using the SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Pruritus score. Improvements in sleep mirrored those in itch; Approximately 60% reached clearance or almost-clearance of skin lesions when assessed using the Investigator's Global Assessment (IGA) score; Patients' quality of life improved over time, as measured by the Dermatology Life Quality Index (DLQI).

Results also reinforce Nemluvio's rapid onset of action on itch and skin at Week 4, with 49% of patients who entered the long-term extension study naive to Nemluvio achieving a 75% reduction in the EASI, and 69% achieving an at least four- point improvement in itch when assessed using the SCORAD VAS Pruritus score. Additional data from both the ARCADIA program in atopic dermatitis, as well as from the OLYMPIA open-label extension study in prurigo nodularis will be presented at RAD 2025, reinforcing Nemluvio's rapid impact on key symptoms of atopic dermatitis, and its long-term efficacy in prurigo nodularis.