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Prurigo nodularis on the arm | Image credit: © DermNet

January 2024

Cryosim-1 Safe, Effective in Patients With Prurigo Nodularis

A clinical trial exploring the safety and efficacy of topical cryosim-1, a synthetic transient receptor potential melastatin 8 (TRPM8) agonist, found that cryosim-1 was both safe and effective in patients with prurigo nodularis.

The study, published in the Journal of Cosmetic Dermatology, sought to investigate the safety and efficacy of a topical TRPM8 agonist in this indication. Researchers Choi et al noted that while several topical and systemic therapeutic options have been researched for prurigo nodularis, none have yet been approved by the FDA.

Prior studies, Choi et al wrote, have explored and proven the efficacy of cryosim-1 in conditions such as eczema, urticaria, and localized scalp pruritus, and therefore it may have the capability to block itching sensations associated with prurigo nodularis.

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February 2024

FDA Accepts Galderma’s BLA for Nemolizumab for the Treatment of Prurigo Nodularis and Atopic Dermatitis

Galderma recently announced that the FDA has accepted its biologics license application (BLA) for nemolizumab for the treatment of prurigo nodularis and adolescents and adults with moderate to severe atopic dermatitis. The FDA has also granted nemolizumab Priority Review for prurigo nodularis. Previously, the FDA granted nemolizumab Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis in December 2019.

Nemolizumab is a first-in-class investigational monoclonal antibody specifically designed to inhibit IL-31 signaling to provide safe and rapid relief from itch.

“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 discussing the latest phase 3 OLYMPIA 2 data of nemolizumab for prurigo nodularis published in the New England Journal of Medicine.

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March 2024

Late-Breaking Data: Long-Term Safety and Efficacy of Largest Prurigo Nodularis Study Ever Conducted

“To give context to this study, we're here at the largest dermatology meeting in the history of the world, and I just presented the largest and longest prurigo nodularis study in the history of the world. We've never had a prurigo nodularis study going longer than 6 months,” said Shawn Kwatra, MD, in an interview after his late-breaking data presentation at the 2024 American Academy of Dermatology Annual Meeting in San Diego, California.

Kwatra presented new data on nemolizumab demonstrating its long-term and increasing efficacy on skin lesions and improved itch in prurigo nodularis through week 52 in the OLYMPIA long-term extension (LITE) study.

The OLYMPIA open-label LTE study builds on the positive data from OLYMPIA 1 and OLYMPIA 2 and is an ongoing 184-week trial evaluating nemolizumab monotherapy in patients with moderate to severe prurigo nodularis. Patients in OLYMPIA LTE included those who had received nemolizumab in phase 2 and 3 lead-in trials as well as those who had previously received placebo.

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April 2024

Incyte and CMS Collaborate to Develop Povorcitinib in Numerous Chinese Regions

Incyte recently announced its new collaboration and license agreement with China Medical System Holdings Limited (CMS) for the research, development, and commercialization of povorcitinib in Mainland China, Hong Kong, Macao, Taiwan Region, and 11 Southeast Asian countries, as well as a non-exclusive license to manufacture povorcitinib in CMS’ territory.

Povorcitinib is a selective oral JAK1 inhibitor currently being evaluated for the treatment of non-segmental vitiligo, hidradenitis suppurativa, prurigo nodularis, asthma, and chronic spontaneous urticaria.

Based on their agreement, CMS will make an upfront payment to Incyte, and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of povorcitinib in CMS’ territory.

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May 2024

Baldo Scassellati Sforzolini, MD, PhD, MBA: Expanding Nemolizumab’s Access

Earlier in May, Galderma announced that it received filing acceptances for nemolizumab for the treatment of prurigo nodularis and moderate to severe atopic dermatitis in 4 additional countries, including Australia, Singapore, Switzerland, and the United Kingdom. The regulatory authorities of Australia, Singapore, Switzerland, and the United Kingdom are members of the Access Consortium and an approval decision from the consortium is expected in 2025.

The US Food and Drug Administration (FDA) and the European Medicines Agency accepted filing submissions for nemolizumab in February 2024. The FDA’s US decision is expected in 2024. Additionally, the FDA granted nemolizumab Priority Review for prurigo nodularis.

The regulatory submissions of nemolizumab in prurigo nodularis are based on data from the phase 3 OLYMPIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every 4 weeks in patients with prurigo nodularis. In the OLYMPIA program, patients treated with nemolizumab monotherapy showed clinically and statistically significant improvements in both primary end points compared to placebo after 16 weeks of treatment.

To further discuss the significance of additional regulatory filing acceptances of nemolizumab for prurigo nodularis, Dermatology Times spoke to Baldo Scassellati Sforzolini, MD, PhD, MBA, the global head of research and development at Galderma.

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August 2024

FDA Approves Nemolizumab for the Treatment of Prurigo Nodularis

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. The FDA initially granted nemolizumab Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024.

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.

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September 2024

Abrocitinib Shows Promise for Prurigo Nodularis

Prurigo nodularis (PN) is often more debilitating than other inflammatory skin diseases due to the relentless itch-scratch cycle and limited effective treatments. PN involves complex interactions between the immune system and neural pathways, with elevated levels of inflammatory cells and cytokines like IL-4 and IL-31 contributing to severe itching. Recent advances in treatment include dupilumab, a dual IL-4 and IL-13 inhibitor approved by the FDA in September 2022, which has shown a favorable response in most patients.

Additionally, nemolizumab, an anti-IL-31 receptor alpha inhibitor, has demonstrated positive results in phase 3 trials, and abrocitinib, a JAK1 inhibitor, is currently in phase 2 trials. Notably, 2 patients with refractory PN responded very well to abrocitinib monotherapy.

Research has shown that inflammatory cytokines such as IL-4, IL-13, IL-17, IL-22, IL-31, and oncostatin M are significantly elevated in PN lesional skin, along with increased levels of Th2, Th17, and Th22 cells. These cytokines contribute to pruritus and skin inflammation through specific JAK-STAT signaling pathways. JAK inhibitors, such as abrocitinib, povorcitinib, and ruxolitinib, have shown promise in treating refractory PN, with case reports demonstrating significant improvements.

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