FDA Approves Nemluvio for Prurigo Nodularis Treatment

The U.S. Food and Drug Administration (FDA) has approved Galderma's Nemluvio® (nemolizumab) for the treatment of adults with prurigo nodularis, according to a news release.

Nemolizumab, a monoclonal antibody IL-31 inhibitor, targets a neuroimmune cytokine implicated in prurigo nodularis pathogenesis. The FDA approval follows the drug’s Breakthrough Therapy Designation in 2019 and Priority Review status in February 2024. The approval was based on the positive results from the phase III OLYMPIA 1 and 2 clinical trials, which included over 500 patients and showed significant improvements in key symptoms of prurigo nodularis.

Among the results:

• 56% and 49% of patients treated with nemolizumab in the OLYMPIA 1 and 2 trials, respectively, experienced at least a four-point reduction in itch intensity at Week 16 compared to 16% in the placebo groups.
• 41% of treated patients achieved similar reductions as early as Week 4.
• 26% and 38% of patients in the OLYMPIA 1 and 2 trials, respectively, reached clearance or near-clearance of skin nodules, while 50% and 52% reported at least a four-point reduction in sleep disturbance.

The safety profile of nemolizumab was consistent with previous studies, and it was well tolerated. Galderma said that applications for nemolizumab in both prurigo nodularis and atopic dermatitis are under review by authorities in the European Union, Canada, and other countries.

"The itch world work up this morning with the FDA approval of nemolizumab for prurigo nodularis," said Shawn Kwatra, MD, lead investigator on the Olympia trial program, in a statement on social media. "This has been an incredible journey from bench to bedside resulting in a breakthrough therapy for prurigo nodularis patients, who represent some of our most difficult to treat patients."