The FDA has granted approval to Galderma's Nemluvio (nemolizumab), making it the first IL-31 receptor monoclonal antibody (mAb) available in the U.S. for the treatment of prurigo nodularis. This approval marks a significant advancement in treating the rare skin condition characterized by intensely itchy nodules.
Nemluvio's approval is based on data from the Phase III OLYMPIA 1 and OLYMPIA 2 trials. These studies demonstrated that 16 weeks of treatment with Nemluvio resulted in a clinically significant reduction in itch intensity for a substantial proportion of patients. Specifically, 56% and 49% of patients in the OLYMPIA 1 and OLYMPIA 2 trials, respectively, experienced at least a four-point reduction in itch intensity. This was compared to 16% in both studies' placebo groups (p<0.001).
The efficacy results of Nemluvio are similar to those observed with Dupixent (dupilumab), an IL-4 and IL-13 inhibitor from Sanofi, which was previously the only approved treatment for prurigo nodularis. In the Phase III PRIME trial for Dupixent, a four-point reduction in itch was seen in 44% of patients versus 15.8% for placebo at week 12 (p<0.001), increasing to 60% versus 18.4% at week 24 (p<0.001).
Prurigo nodularis is a chronic, debilitating skin disease characterized by hard, intensely itchy nodules that can significantly impair quality of life. The approval of Nemluvio provides a valuable new option for patients who have had limited treatment alternatives. Galderma's Nemluvio offers a competitive alternative to Sanofi's Dupixent in the treatment landscape for prurigo nodularis.
