Galderma's Nemolizumab Shows Promising Phase III Results in Prurigo Nodularis

Galderma has published full results from the Phase III OLYMPIA 1 trial in JAMA Dermatology, highlighting nemolizumab’s efficacy and safety as a monotherapy for adults with moderate-to-severe prurigo nodularis. The trial met all primary and secondary endpoints, demonstrating significant improvements in itch intensity and skin lesion clearance at Week 16 compared to placebo, with rapid responses observed as early as Week 4.

The 24-week study enrolled 286 patients, revealing that 58.4% of nemolizumab-treated participants achieved at least a four-point improvement in itch, compared to 16.7% in the placebo group. Additionally, 26.3% of patients reached clearance or near-clearance of skin lesions, versus 7.3% in the placebo group. Nemolizumab also provided substantial relief from sleep disturbances, with 50% showing significant improvement by Week 16.

These findings reinforce data from the OLYMPIA 2 trial and have led to the FDA's approval of nemolizumab under the brand name Nemluvio® for prurigo nodularis. Galderma's marketing applications are under review by global regulatory authorities, including the EMA and Access Consortium, expanding potential access to the treatment across Europe, Asia, and the Americas.