The U.S. Food and Drug Administration (FDA) has approved nemolizumab (Nemluvio, Galderma) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.
Nemolizumab specifically inhibits IL-31 cytokine signaling, which is known to drive itch and is involved in inflammation, altered epidermal differentiation, and fibrosis (hardening of skin tissue) in prurigo nodularis.
Nemolizumab was granted Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024 by the U.S. FDA
The approval is based on positive results from the phase III OLYMPIA clinical trials – the largest clinical trial program conducted in this condition to date – in which nemolizumab demonstrated significant and clinically meaningful improvements in itch and skin nodules at Week 16, with rapid reductions in itch observed as early as Week 4.
The phase III OLYMPIA 1 and OLYMPIA 2 clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks in more than 500 patients with prurigo nodularis. The trials met both their primary and key secondary endpoints, demonstrating that:
- 56% and 49% of nemolizumab-treated patients in OLYMPIA 1 and 2 respectively, achieved at least a four-point reduction in itch intensity at Week 16, as measured by the peak-pruritus numerical rating scale, compared to 16% in both placebo groups (p<0.001) (primary endpoint).1
- 41% of nemolizumab-treated patients in OLYMPIA 1 and 2 achieved at least a four-point reduction in itch intensity at Week 4, as measured by the peak-pruritus numerical rating scale, compared to 6% and 7% in the placebo group (p<0.001) (key secondary endpoint).
- 26% and 38% of nemolizumab -treated patients in OLYMPIA 1 and 2 respectively, reached clearance (investigator’s global assessment [IGA] 0) or almost-clearance (IGA 1) of skin nodules at Week 16, when assessed using the IGA score (range: 0-4), compared to 7% and 11% in the placebo group (primary endpoint).
- 50% and 52% of nemolizumab -treated patients in OLYMPIA 1 and 2 respectively, achieved at least a four-point reduction in sleep disturbance at Week 16, as measured by the sleep disturbance numerical rating scale, compared to 12% and 21% in the placebo group (key secondary endpoint).
The trials also met all other key secondary endpoints, confirming rapid reduction of itch due to prurigo nodularis, and sleep disturbance, within four weeks of treatment initiation. Nemolizumab was generally well tolerated, and its safety profile was consistent with the phase II trial, and between the OLYMPIA 1 and 2 trials.
“I’m delighted that Nemluvio has received U.S. FDA approval and I’m looking forward to offering this treatment option to the prurigo nodularis patients in my practice who are in desperate need of fast relief from itch, which negatively impacts their quality of life,” says Shawn Kwatra, MD, the Joseph W. Burnett Endowed Professor and Chair of Dermatology at the University of Maryland (UM) School of Medicine in Baltimore, MD, in a news release. “By inhibiting the signaling of IL-31, Nemluvio addresses a key driver of prurigo nodularis, safely and effectively improving itch as well as skin nodules.”
The U.S. FDA has also accepted for review the Biologics License Application for nemolizumab for the treatment of moderate-to-severe atopic dermatitis, with a decision anticipated later this year. Galderma’s marketing authorization applications for nemolizumab in both prurigo nodularis and atopic dermatitis are under review by multiple regulatory authorities, including the European Medicines Agency and Health Canada, as well as in Australia, Singapore, Switzerland, and the United Kingdom, via the Access Consortium framework. Further submissions to other regulatory authorities will continue throughout 2024.
