The U.S. Food and Drug Administration (FDA) has approved Galderma’s Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of prurigo nodularis in adults. The FDA had previously granted Nemluvio Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024, statuses which are reserved for medicines with the potential to significantly improve the treatment of serious conditions.
The approval of Nemluvio comes after positive results from the phase III OLYMPIA clinical trials, which was the largest clinical trial program that has been conducted for prurigo nodularis to date. During these trials, Nemluvio demonstrated “significant and clinically meaningful improvements in both itch and skin nodules at Week 16, with rapid reductions in itch observed as early as Week 4.”
Lead investigator in the Olympia program, Shawn Kwatra, MD, states, “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. 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.”
Results from the phase III OLYMPIA 1 and OLYMPIA 2 clinical trials evaluated the safety and efficacy of Nemluvio which was administered subcutaneously every four weeks to over 500 patients with the condition. The results are outlined below:
- In OLYMPIA 1 and 2 respectively, 56% and 49% of Nemluvio-treated patients achieved at least a four-point reduction in itch intensity at Week 16 (as measured by the peak-pruritus numerical rating scale). This is compared to 16% in both placebo groups.
- As a key secondary endpoint, 41% of Nemluvio-treated patients in OLYMPIA 1 and 2 achieved at least a four-point reduction in itch intensity at Week 4, compared to 6% and 7% in the placebo group.
- A total of 26% and 38% of Nemluvio-treated patients in OLYMPIA 1 and 2 respectively saw clearance (investigator’s global assessment [IGA] 0) or almost-clearance (IGA 1) of skin nodules at Week 16. This is compared to the 7% and 11% in the placebo group.
- 50% and 52% of Nemluvio-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.
The clinical trials also reveal that Nemluvio was generally well tolerated, showing a safety profile that was consistent with the phase II trial, and between the OLYMPIA 1 and 2 trials.
Chief executive officer of Galderma, Flemming Ørnskov, MD, MPH, states “The U.S. FDA’s rapid approval of Nemluvio in prurigo nodularis is a first step in achieving its blockbuster platform potential and reinforces our leadership in therapeutic dermatology. We’re confident in the impact this first-in-class therapy will have for patients with prurigo nodularis who urgently need more treatment options and look forward to potentially bringing Nemluvio to patients with other itch-related skin diseases in the near future.”
In addition to this latest news, the FDA has also accepted for review the Biologics License Application for Nemluvio for the treatment of moderate-to-severe atopic dermatitis. It is expected a decision will be made later this year.
Source:
- Galderma receives U.S. FDA approval for Nemluvio® (nemolizumab) for adult patients living with prurigo nodularis. (n.d.). Galderma. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo
