Nemolizumab Granted FDA Approval For Adults Living With Prurigo Nodularis
Nemolizumab is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31, which drives disease mechanisms in prurigo nodularis.
Updated at 10:00 am on August 13, 2024.
The FDA announced today that nemolizumab (Nemluvio; Galderma) has been approved as a pre-filled pen for subcutaneous injection to treat adults living with prurigo nodularis, according to a news release by Galderma.1
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Nemolizumab was previously granted breakthrough therapy designation in December 2019, and Galderma’s regulatory filing for priority review of the drug was approved in February 2024 by the FDA. This status is granted to medicines that have potential to significantly improve the treatment of rare conditions.2,3
“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,” Flemming Ørnskov, CEO of Galderma, said in the news release.1
Nemolizumab’s approval is based on positive results from the phase 3 OLYMPIA clinical trials, which is the largest clinical trial program conducted for prurigo nodularis to date. In the trial, 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 in some patients.1
Additionally, the phase 3 OLYMPIA 1 (NCT04501666) and OLYMPIA 2 (NCT04501679) trials found that 56% and 49% of nemolizumab-treated patients, respectively, achieved at least a 4-point reduction in itch intensity at week 16. These trials evaluated more than 500 patients with prurigo nodularis, and each met their primary and key secondary end points.1
Nemolizumab has shown promise as a treatment since 2017, when a study indicated it was effective in reducing itching and clearing up dry skin patches in patients with atopic dermatitis. Seven years later, the drug has reached FDA-approved status.4
In that study, 216 patients were randomized to receive either a placebo or a low, moderate, or high dose of nemolizumab injected once per month. According to the results, there was a 44% reduction in itching for the low-dose arm; 60% reduction for the moderate-dose group; and 63% less itching in the high-dose cohort.4
“I’m delighted that Nemluvio has received US FDA approval and I’m looking forward to offering this treatment option to the prurigo nodularis patients in my practice who in desperate need of fast relief from itch, which negatively impacts their quality of life,” Shawn Kwatra, lead investigator of the OLYMPIA program, said in the news release.1
Prurigo nodularis is an underdiagnosed neuroimmune skin disease which affects an estimated 180,000 individuals in the United States. Debilitating symptoms characterize the disease, including chronic itch, poor quality of sleep, and skin nodules covering large areas of the body.1
Nemolizumab inhibits IL-31 cytokine signaling, which is known to drive itch and is involved in inflammation, fibrosis, and altered epidermal differentiation in prurigo nodularis. The drug is the first approved monoclonal antibody that specifically inhibits IL-31 signaling.1
In addition to its acceptance by the FDA, the agency also accepted for review the Biologics License Application for nemolizumab for the treatment of moderate-to-severe atopic dermatitis.1
