FDA Approves First Monoclonal Antibody to Treat Prurigo Nodularis

The FDA has approved nemolizumab (Nemluvio) for the treatment of prurigo nodularis in adult patients, Galderma said in a release.¹ The therapy inhibits the signaling of IL-31 and comes in a pre-filled pen that is intended for subcutaneous injection. It is the first monoclonal antibody approved to treat the chronic skin condition.

The approval of nemolizumab was based on data from the phase 3 OLYMPIA 1 (NCT04501666) and OLYMPIA 2 (NCT04501679) clinical trials, in which the therapy met its primary endpoints of an improvement of 4 or greater in weekly average peak Pruritus Numeric Rating Scale at week 16 and an Investigator Global Assessment success at week 16. Nemolizumab also met all of its key secondary endpoints, including number of adverse events and an improvement of 4 or more in Sleep Disturbance Numeric Rating Scale at week 16.

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“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 are in desperate need of fast relief from itch, which negatively impacts their quality of life,” Shawn Kwatra, MD, PhD, lead investigator of the OLYMPIA program, said in a release.¹ “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.”

OLYMPIA 1 and 2 were both randomized, double-blind, placebo-controlled phase 3 trials that evaluated the efficacy and safety of nemolizumab in adult patients who had a prurigo nodularis diagnosis for at least 6 months. OLYMPIA 1 included 286 patients and OLYMPIA 2 included 274 patients. Patients received placebo or either 30 mg or 60 mg of nemolizumab administered subcutaneously every 4 weeks.

Investigators found that 56% and 49% of patients treated with nemolizumab achieved at least a 4-point reduction in itch intensity at week 16 in OLYMPIA 1 and 2, respectively. At week 16, 26% and 38% of treated patients reached clearance or almost-clearance of skin nodules in OLYMPIA 1 and 2, respectively. Additionally, 50% and 52% of treated patients achieved at least a 4-point reduction in sleep disturbance at week 16 in OLYMPIA 1 and 2, respectively.

The therapy was also seen to be generally well tolerated, with a safety profile similar to results from a phase 2 trial. The most commonly reported adverse events were headache and skin rashes, including eczema, atopic dermatitis, and eczema nummular.²

Galderma said in the release that the FDA has also accepted a biologics license application for nemolizumab to treat moderate to severe atopic dermatitis. The company said it anticipates a decision on the application later this year.

“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, MD, MPH, CEO at Galderma, said in a release.¹ “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.”

READ MORE: Dermatology Resource Center

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References

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

2. Kwatra SG, Yosipovitch G, Legat FJ, at al. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med. 2023 Oct 26;389(17):1579-1589. doi: 10.1056/NEJMoa2301333. PMID: 37888917.