Nemolizumab Approved by European Commission for Moderate-to-severe Prurigo Nodularis

Nemolizumab has been approved by the European Commission for the treatment of moderate-to-severe prurigo nodularis, according to an announcement from Galderma.

The approval of the monoclonal antibody (marketed as Nemluvio) follows positive results from two phase 3 clinical trials (from the ARCADIA and OLYMPIA trial programs), which showed significant reductions in itch severity and skin lesions compared to placebo in adults with prurigo nodularis. According to Galderma, Nemolizumab is the first treatment in the EU specifically approved for this condition.

"Atopic dermatitis and prurigo nodularis can severely impact quality of life due to the associated debilitating symptoms, including chronic itch, skin lesions, poor sleep quality and mental health conditions," said Prof. Diamant Thaci, of the University of Lubeck, and lead investigator of the ARCARIA trial program, in the news release. "With this approval, patients in the EU have a new treatment option, which extensive data has shown can help to safely, quickly, and effectively ease the key symptoms of these diseases and therefore the burden on patients’ lives.”

Galderma plans to make the drug available across the EU in the coming months. The approval builds on Nemolizumab’s existing recognition in Japan for atopic dermatitis, underscoring its broad dermatological potential, the manufacturer said.

“Nemolizumab’s benefits have been demonstrated in its comprehensive clinical trial programs in both atopic dermatitis and prurigo nodularis, including the OLYMPIA 1 and 2 studies, which make up the largest completed pivotal program in prurigo nodularis to date," said Prof. Sonja Stander, of the University Hospital Munster, and lead investigator of the OLYMPIA trial program, in the press release. "These clinical data, plus its first-in-class mechanism of action and convenient dosing schedule, make it an important new therapeutic solution for dermatologists to support their patients.”

Source: Galderma press release. February 14, 2025.