FDA Approves Nemolizumab for Treatment of Prurigo Nodularis

On August 13, an approval by the US Food and Drug Administration (FDA) was announced for nemolizumab (Nemluvio) treatment of adults with prurigo nodularis, a chronic neuroimmune skin condition known to impact around 181,000 US patients and characterized by intense pruritus.¹

Nemolizumab is administered subcutaneously using a pre-filled pen. The medication was granted Breakthrough Therapy Designation in December 2019 and then granted Priority Review in February 2024 by FDA officials.

“I’m delighted that (nemolizumab) has received US 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,” Shawn Kwatra, MD, associate professor of dermatology at Johns Hopkins University School of Medicine, said in a statement. “By inhibiting the signaling of IL-31, (nemolizumab) addresses a key driver of prurigo nodularis, safely and effectively improving itch as well as skin nodules.”

Prurigo nodularis is a disease which is frequently underdiagnosed and often features a set of symptoms which can be debilitating, such as skin nodules featured on large bodily regions, chronic itch, and poor quality of sleep. The Galderma announcement notes the significant burden patients face as well as the necessity of alternative therapy options.

Nemolizumab inhibits signaling of the interluekin (IL)-31 cytokine pathway. IL-31 signaling is known to drive pruritus and is associated with changes in epidermal differentiation, inflammation, and fibrosis among individuals who suffer from prurigo nodularis.

The FDA’s approval of the drug follows the positive results from the phase 3 OLYMPIA clinical trial designed to assess the safety and efficacy of nemolizumab in 500 subjects on a dosing regimen of every 4 weeks. Both the primary and secondary endpoints were met, with the drug leading to clinically meaningful and significant itch and skin nodule improvements at the 16-week mark.

Specifically, 56% and 49% of OLYMPIA 1 and 2 participants treated with nemolizumab, respectively, had at minimum a 4-point reduction itch intensity reduction. This was measured by the peak-pruritus numerical rating scale, and it contrasted with 16% in both trials’ placebo arms (P < .001).

The research team also noted 26% and 38% of those in OLYMPIA 1 and 2 treated with nemolizumab, respectively, reported clearance of nodules at the 16-week mark (Investigator’s Global Assessment [IGA] 0) or almost-clearance (IGA 1) when evaluated with the IGA score (range: 0-4). This was compared to 7% and 11% among those in the placebo arm (P < .001).

The OLYMPIA trial investigators also noted rapid itch reductions among study participants, observed as early as the 4-week mark. Specifically, 41% of treated subjects in OLYMPIA 1 and 2 were shown to have a 4-point itch intensity reduction at minimum by the 4-week mark versus the 6% and 7% rates seen among the placebo arm (P < .001).

Additionally, the research team highlighted that in both trials, 50% and 52% of treated subjects, respectively, had at least a 4-point sleep disturbance reduction by the 16-week mark, versus 12% and 21% among those in the placebo arm (P < .001).

“The US 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," said Flemming Ørnskov, MD, MPH, chief executive officer of Galderma. "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.”

A decision on the FDA’s review of nemolizumab’s Biologics License Application for the moderate-to-severe atopic dermatitis treatment is slated for later in 2024.

References

1. ^{Galderma Receives U.S. FDA Approval for Nemluvio® (nemolizumab) for Adult Patients Living With Prurigo Nodularis. Galderma. August 13, 2024. https://www.businesswire.com/news/home/20240812791599/en/Galderma-Receives-U.S.-FDA-Approval-for-Nemluvio%C2%AE-nemolizumab-for-Adult-Patients-Living-With-Prurigo-Nodularis. Date accessed: August 13, 2024.}
2. ^{Smith T. Shawn Kwatra, MD: Implications of new data on nemolizumab, prurigo nodularis. HCP Live. October 31, 2023. Accessed August 15, 2024. https://www.hcplive.com/view/shawn-kwatra-implications-new-data-nemolizumab-prurigo-nodularis.}