FDA Approves Nemolizumab for the Treatment of Prurigo Nodularis

Image credit: © Calin - stock.adobe.com

Galderma recently announced that the US Food and Drug Administration (FDA) approved nemolizumab (Nemluvio) as a pre-filled pen for subcutaneous injection for the treatment of adult patients with prurigo nodularis.¹ The FDA initially granted nemolizumab Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024.^2,3

“Because this patient population has suffered for a long time, anytime there's a hope of new therapeutics, it's very exciting for doctors and for patients; nemolizumab has the potential to be a very significant addition to our armamentarium against treating itch,” said Shawn Kwatra, MD, in a previous interview with Dermatology Times. Kwatra, associate professor of dermatology at Johns Hopkins University School of Medicine and director of the Johns Hopkins Itch Center, in Baltimore, Maryland, and an OLYMPIA investigator, discussed the latest phase 3 OLYMPIA 2 data of nemolizumab for prurigo nodularis published in the New England Journal of Medicine.

Prurigo nodularis is associated with chronic itch, skin nodules covering large body areas, and poor sleep quality. Based on the need for a specific therapeutic to address the symptoms of prurigo nodularis, nemolizumab inhibits IL-31 cytokine signaling to target itch, inflammation, altered epidermal differentiation, and fibrosis.

"By targeting and blocking this neuroimmune cytokine signaling, which drives key symptoms of prurigo nodularis, nemolizumab has the potential to rapidly and effectively address the most burdensome symptom for people with prurigo nodularis – itch, as well as the appearance of skin nodules,” said Baldo Scassellati Sforzolini, MD, PhD, MBA, the global head of research and development at Galderma, in a previous interview with Dermatology Times.

The approval of nemolizumab is based on positive data from the phase 3 OLYMPIA clinical trials which were the largest clinical trial program for prurigo nodularis conducted to date. OLYMPIA 1 (NCT04501679) and OLYMPIA 2 (NCT04501666) evaluated the safety and efficacy of nemolizumab administered subcutaneously every 4 weeks in more than 500 patients with prurigo nodularis.

Key data from the primary and secondary end points included:

• 56% and 49% of patients treated with nemolizumab in OLYMPIA 1 and 2 respectively, achieved at least a 4-point reduction in itch intensity at week 16, as measured by the Peak-Pruritus Numerical Rating Scale, compared to 16% in both placebo groups (p<0.001) (primary end point)
• 41% of patients treated with nemolizumab in OLYMPIA 1 and 2 achieved at least a 4-point reduction in itch intensity at week 4, as measured by the peak-pruritus numerical rating scale, compared to 6% and 7% in the placebo group (p<0.001) (key secondary endpoint)
• 26% and 38% of patients treated with nemolizumab in OLYMPIA 1 and 2 respectively, reached clearance (Investigator’s Global Assessment [IGA] 0) or almost-clearance (IGA 1) of skin nodules at week 16, when assessed using the IGA score (range: 0-4), compared to 7% and 11% in the placebo group (p<0.001) (primary end point)
• 50% and 52% of patients treated with nemolizumab in OLYMPIA 1 and 2 respectively, achieved at least a 4-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) (key secondary end point)

"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. 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, chief executive officer of Galderma, in the news release.

Additionally, the FDA has also accepted for review Galderma’s Biologics License Application for nemolizumab for the treatment of moderate to severe atopic dermatitis. A decision from the FDA is expected at the end of 2024.

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#:~:text=Zug%2C%20Switzerland%20%E2%80%93%20August%2013%2C,of%20adults%20with%20prurigo%20nodularis.
2. Galderma investigational therapy nemolizumab granted FDA Breakthrough Therapy Designation for the treatment of patients suffering from prurigo nodularis. News release. Galderma. December 9, 2019. Accessed August 13, 2024. https://www.galderma.com/news/galderma-investigational-therapy-nemolizumab-granted-fda-breakthrough-therapy-designation
3. Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU. News release. Galderma. February 14, 2024. Accessed August 13, 2024. https://www.galderma.com/news/galderma-announces-regulatory-filing-acceptance-nemolizumab-prurigo-nodularis-and-atopic