FDA Approves Galderma’s Nemluvio for Treating Adults with Prurigo Nodularis

Image Credit: Adobe Stock Images/MdBabul

The FDA has approved Galderma’s Nemluvio (nemolizumab), a subcutaneous injection treatment designed for adults with prurigo nodularis. According to the company, approval was based on results of the Phase III OLYMPIA trials, which followed Nemluvio;’s designation as a Breakthrough Therapy in 2019 and Priority Review status earlier this year. The trials found that Nemluvio significantly reduces itch and skin nodules, with improvements seen as early as Week 4 and sustained through Week 16.¹

“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,” said Flemming Ørnskov, MD, MPH, CEO, Galderma, in a press release.

OLYMPIA 1 and OLYMPIA 2 were two identically designed, pivotal clinical trials that consisted of 560 patients. According to Galderma, this was the largest clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study. The trials aimed to assess the efficacy and safety of Nemluvio monotherapy compared with placebo in patients over the age of 18 years old with moderate-to-severe prurigo nodularis over a 16- or 24-week treatment period. The primary endpoint of the study was a four-point reduction in itch intensity at Week 16, as measured by the peak-pruritus numerical rating scale. The secondary endpoint was a four-point reduction in itch intensity at Week 4, as measured by the peak-pruritus numerical rating scale.

Results found that 56% and 49% of Nemluvio-treated patients in OLYMPIA 1 and 2 respectively achieved at least a four-point reduction in itch intensity at Week 16, meeting the primary endpoint of the trials. Additional results found:

• 41% of Nemluvio-treated patients in both trials achieved at least a four-point reduction in itch intensity at Week 4 compared to 6% and 7% in the placebo group.
• 26% of Nemluvio-treated patients in OLYMPIA 1 and 38% in OLYMPIA 2 reached clearance or near-clearance of compared to 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.

Serious adverse events (AEs) related to treatment with Nemluvio include joint pain, breathing problems, fever, skin rash, nausea or vomiting, swelling of the face, lips, mouth, tongue, or throat, fainting, dizziness, fast pulse, swollen lymph nodes, and stomach cramps. Common AEs include headaches and skin rashes such as eczema, atopic dermatitis, and eczema nummular.

Galderma stated that the FDA has also accepted the Biologics License Application for Nemluvio for the treatment of moderate-to-severe atopic dermatitis, expecting a decision to be made by the end of this year. Further marketing authorizations are currently under review by multiple regulatory authorities, including the European Medicines Agency, Health Canada, Australia, Singapore, Switzerland, and the United Kingdom, via the Access Consortium framework.¹

“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,” said Shawn Kwatra, MD, lead investigator, OLYMPIA program, Joseph W. Burnett endowed professor, chairman, dermatology, University of Maryland School of Medicine, in the press release.

Reference

1. Galderma receives U.S. FDA approval for Nemluvio® (nemolizumab) for adult patients living with prurigo nodularis. Galderma. August 13, 2024. Accessed August 13, 2024. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo