The U.S. Food and Drug Administration (FDA) has approved Galderma's Nemluvio (nemolizumab-ilto) for the treatment of adult patients with prurigo nodularis. This marks a significant advancement in treating this chronic and debilitating skin condition, affecting an estimated 181,000 people in the United States.
Nemolizumab is the first approved monoclonal antibody that specifically inhibits the signaling of interleukin-31 (IL-31), a key neuroimmune cytokine driving the disease mechanisms of prurigo nodularis. The drug is administered as a subcutaneous injection via a pre-filled pen.
Clinical Efficacy
The approval is based on data from the Phase III OLYMPIA 1 and OLYMPIA 2 clinical trials, which represent the largest clinical trial program conducted for prurigo nodularis to date. These trials enrolled over 500 patients and evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks.
The OLYMPIA trials met both primary and key secondary endpoints:
- In OLYMPIA 1, 56% of nemolizumab-treated patients achieved at least a four-point reduction in itch intensity at Week 16, compared to 16% in the placebo group (p<0.001).
- In OLYMPIA 2, 49% of nemolizumab-treated patients achieved at least a four-point reduction in itch intensity at Week 16, compared to 16% in the placebo group (p<0.001).
- Significant itch reduction was observed as early as Week 4, with 41% of nemolizumab-treated patients in OLYMPIA 1 and 2 achieving at least a four-point reduction in itch intensity, compared to 6% and 7% in the placebo groups (p<0.001).
- In OLYMPIA 1, 26% of nemolizumab-treated patients achieved clearance (IGA 0) or almost-clearance (IGA 1) of skin nodules at Week 16, compared to 7% in the placebo group (p<0.001).
- In OLYMPIA 2, 38% of nemolizumab-treated patients reached clearance or almost-clearance of skin nodules at Week 16, compared to 11% in the placebo group (p<0.001).
- 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 (p<0.001).
Dr. Shawn Kwatra, lead investigator of the OLYMPIA program and professor at the University of Maryland School of Medicine, stated, "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."
Safety and Tolerability
Nemolizumab was generally well-tolerated in the clinical trials, with a safety profile consistent with previous Phase II trials. Common side effects included headache and skin rashes, such as eczema and atopic dermatitis.
Addressing Unmet Needs
Prurigo nodularis is characterized by chronic, intense itch and the presence of thick skin nodules. The condition significantly impairs patients' quality of life, leading to sleep disturbances and other debilitating symptoms. Current treatment options have been limited, highlighting the need for alternative therapies like nemolizumab.
Future Applications
Galderma is also pursuing regulatory approval for nemolizumab in treating moderate-to-severe atopic dermatitis. The FDA has accepted the Biologics License Application for this indication, with a decision anticipated later this year. Marketing authorization applications are also under review by the European Medicines Agency, Health Canada, and other regulatory authorities worldwide.
Flemming Ørnskov, M.D., MPH, CEO of Galderma, noted, "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."
