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Nemolizumab (Nemluvio, Galderma) Shows Sustained Improvements in Itch and Lesions in PN

Nemolizumab (Nemluvio, Galderma) is well tolerated and produces sustained and clinically meaningful improvements in symptoms including itch and skin lesions in moderate-to-severe prurigo nodularis for up to two years, according to a new interim analysis of the OLYMPIA long-term extension study.

The research will be presented as a late-breaking abstract at the XIV International Congress of Dermatology (ICD) in Rome, Italy.

The OLYMPIA long-term extension study was designed to assess the safety and efficacy of nemolizumab in patients with PN up to four years and includes 508 patients from the Phase 2 trial or the Phase 3 OLYMPIA 1 and 2 trials. Results show that treatment with nemolizumab is associated with sustained and clinically meaningful improvements in symptoms of PN during prolonged treatment up to two years.

Interim Analysis Results

At Week 100 in evaluable patients, the interim analysis showed that:

  • More than 90% and 70% achieved at least a four-point improvement in itch, and being itch free or nearly itch free respectively, as measured by the Peak-Pruritus Numerical Rating Scale.
  • At least 80% achieved 76 100% healed pruriginous lesions.
  • Approximately 75% reached clearance or almost-clearance of skin nodules when assessed using the Investigator’s Global Assessment score.
  • Nemolizumab was well tolerated in the long-term treatment of prurigo nodularis, and no new safety signals were identified in this study to date.

“These impressive results give us even more confidence in the value of nemolizumab—a much-needed innovative medicine that has the potential to deeply impact the prurigo nodularis treatment landscape. With this new treatment now approved in multiple markets, including the EU and U.S., I’m thrilled to be able to see its meaningful impact in the real world,” says Sonja Ständer, MD, a Professor of Dermatology and Neurodermatology at the University of Münster and head of the interdisciplinary Center for Chronic Pruritus (KCP) at the University Hospital Münster in Münster, Germany, in a news release.