James Del Rosso, DO, provides an overview of nemolizumab for prurigo nodularis, including clinical trial outcomes, mechanism of action, and more. 

Galderma has achieved a significant milestone with the US Food and Drug Administration's (FDA) approval of Nemluvio (nemolizumab) for the treatment of adults with prurigo nodularis. Nemluvio, delivered via a prefilled pen for subcutaneous injection, is the first monoclonal antibody specifically designed to inhibit IL-31 signaling—a critical pathway involved in the pathogenesis of prurigo nodularis. 

Clinical trial insights 

Nemluvio's approval is grounded in robust data from the phase III OLYMPIA clinical trials, which evaluated its efficacy and safety in more than 500 patients with prurigo nodularis. Patients treated with Nemluvio demonstrated substantial and clinically meaningful reductions in itch, with 56% and 49% of participants in the OLYMPIA 1 and 2 trials, respectively, achieving at least a 4-point reduction in itch by Week 16, compared to 16% in the placebo groups. Notably, improvements were observed as early as Week 4, with 41% of Nemluvio-treated patients experiencing significant itch reduction compared to 6% and 7% in the placebo groups. 

Nemluvio significantly improved skin nodules. By Week 16, 26% and 38% of patients in the OLYMPIA 1 and 2 trials, respectively, achieved either complete or near-complete clearance of skin nodules, compared to 7% and 11% in the placebo groups. 

Safety profile 

Nemluvio was generally well tolerated in the OLYMPIA trials, with a safety profile consistent with earlier phase II studies. The most common side effects reported included headache, eczema, atopic dermatitis, and nummular eczema. 

Future outlook 

Looking ahead, Nemluvio’s potential extends beyond prurigo nodularis. The FDA has also accepted a Biologics License Application for Nemluvio for the treatment of moderate-to-severe atopic dermatitis, with a decision expected later this year. This development positions Nemluvio as a promising therapeutic option for other IL-31-mediated conditions, signaling a broader impact in the field of dermatology.