Galderma (SWX:GALD) has announced that the European Commission has granted approval for Nemluvio, a groundbreaking biologic therapy, for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis within the European Union (EU). This regulatory milestone paves the way for Nemluvio to be available as a subcutaneous treatment option for patients aged 12 years and older who require systemic therapy for atopic dermatitis, as well as for adults suffering from moderate-to-severe prurigo nodularis who are also eligible for systemic treatment.
A Landmark Advancement in Dermatology
The approval of Nemluvio marks a significant achievement for Galderma, a company with over four decades of dedication to dermatology and patient care. This milestone underscores Galderma’s ongoing commitment to delivering innovative treatment options that address the unmet needs of patients with dermatological conditions. According to Flemming Ørnskov, M.D., MPH, Chief Executive Officer of Galderma, Nemluvio’s approval exemplifies the company’s mission to expand its therapeutic dermatology portfolio with cutting-edge solutions.
“Throughout Galderma’s four decades in dermatology, we have consistently worked to meet the needs of patients and deliver first-in-class treatment options. This has been exemplified through the clinical and regulatory success achieved with our unique monoclonal antibody, Nemluvio. As the first biologic treatment in our Therapeutic Dermatology portfolio, Nemluvio shows our commitment to advancing dermatology by expanding into new areas of need.”
A Unique Mechanism of Action
Nemluvio is the first approved monoclonal antibody specifically designed to target the IL-31 receptor alpha, thereby inhibiting the signaling of IL-31. IL-31 is a neuroimmune cytokine that plays a critical role in driving itch and inflammation, contributing to skin barrier dysfunction in atopic dermatitis and prurigo nodularis. Additionally, IL-31 is involved in fibrosis in prurigo nodularis.
The drug’s mechanism of action sets it apart as the first and only biologic therapy approved for both atopic dermatitis and prurigo nodularis that utilizes a four-week dosing schedule from the initiation of treatment. This dosing regimen offers patients a convenient and effective option for managing these chronic conditions.
Robust Clinical Trial Data Supporting Approval
The European Commission’s decision to approve Nemluvio was based on compelling data from two large-scale Phase III clinical trial programs: ARCADIA and OLYMPIA. These trials evaluated the efficacy and safety of Nemluvio in improving symptoms such as itch, skin lesions, and sleep disturbances in patients with moderate-to-severe atopic dermatitis and prurigo nodularis.
Findings from the ARCADIA Trials
The ARCADIA 1 and ARCADIA 2 trials assessed the effects of Nemluvio in patients with moderate-to-severe atopic dermatitis who were receiving background therapy with topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI). Patients were administered Nemluvio subcutaneously every four weeks.
Key findings from these trials demonstrated that:
- Nemluvio treatment led to statistically significant improvements in skin clearance compared to the placebo group by Week 16.
- Both co-primary endpoints of the trials were met, confirming its efficacy.
- Secondary endpoints showed that patients experienced significant relief from itch as early as Week 1.
- Notably, there were significant improvements in sleep quality, addressing a major concern for patients with atopic dermatitis.
Findings from the OLYMPIA Trials
The OLYMPIA 1 and OLYMPIA 2 trials evaluated Nemluvio’s effectiveness in treating moderate-to-severe prurigo nodularis as a monotherapy. The results mirrored those from the ARCADIA trials, with significant improvements in key clinical parameters:
- Patients treated with Nemluvio experienced meaningful reductions in itch severity and skin lesions by Week 16 compared to the placebo group.
- The therapy was shown to provide rapid itch relief, with significant improvements seen within four weeks of initiating treatment.
- Improvements in sleep disturbances were also reported, which is a critical factor for improving patients’ quality of life.
Overall, Nemluvio was well tolerated across all trials, with its safety profile remaining consistent with previous clinical studies. These findings underscore the drug’s potential to become a transformative option for patients suffering from these chronic skin conditions.
Expert Endorsements
Leading dermatologists and investigators involved in the ARCADIA and OLYMPIA studies have emphasized the importance of Nemluvio as a new therapeutic option. Professor Diamant Thaçi, a lead investigator of the ARCADIA studies from the University of Lübeck, Germany, highlighted the significant impact that atopic dermatitis and prurigo nodularis have on patients’ quality of life:
“Atopic dermatitis and prurigo nodularis can severely impact quality of life due to the associated debilitating symptoms, including chronic itch, skin lesions, poor sleep quality, and mental health conditions. With this approval, patients in the EU have a new treatment option, which extensive data has shown can help to safely, quickly, and effectively ease the key symptoms of these diseases and therefore reduce the burden on patients’ lives.”
Similarly, Professor Sonja Ständer from the University Hospital Münster, Germany, emphasized the extensive clinical evidence supporting Nemluvio:
“Nemolizumab’s benefits have been demonstrated in its comprehensive clinical trial programs in both atopic dermatitis and prurigo nodularis, including the OLYMPIA 1 and 2 studies, which make up the largest completed pivotal program in prurigo nodularis to date. These clinical data, plus its first-in-class mechanism of action and convenient dosing schedule, make it an important new therapeutic solution for dermatologists to support their patients.”
Global Regulatory Progress and Market Expectations
Nemluvio has already received approval from the U.S. Food and Drug Administration (FDA) for the treatment of both atopic dermatitis and prurigo nodularis. Additionally, the drug is currently under review by several regulatory authorities worldwide, including Canada, Brazil, South Korea, and countries within the Access Consortium, such as Australia, Singapore, and Switzerland. Further regulatory submissions are ongoing in other regions.
From a market perspective, Galderma anticipates that Nemluvio will achieve peak sales exceeding $2 billion beyond the 2023-2027 mid-term guidance period. The company also expects the drug to reach ‘blockbuster’ net sales status by the end of 2027.
