Galderma’s Nemluvio® (Nemolizumab) EU Approval for Atopic Dermatitis and Prurigo Nodularis
Galderma announced that the European Commission has granted approval for Nemluvio® (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio, a monoclonal antibody, is now approved for subcutaneous administration for patients aged 12 and older with moderate-to-severe atopic dermatitis who are candidates for systemic therapy, as well as for adults with moderate-to-severe prurigo nodularis who are also candidates for systemic therapy.
Flemming Ørnskov, M.D., MPH, CEO of Galderma, expressed the company’s excitement about this approval, emphasizing the significance of Nemluvio in their portfolio. “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 approval exemplifies our commitment to advancing dermatology through innovative treatments,” he said. Nemluvio is the first biologic therapy introduced into Galderma’s Therapeutic Dermatology portfolio, marking a new era for the company in meeting patient needs.
Nemluvio works by targeting and inhibiting IL-31 receptor alpha, blocking the signaling of IL-31, a cytokine involved in both inflammation and skin barrier dysfunction in atopic dermatitis and prurigo nodularis. Additionally, it addresses the neuroimmune response responsible for the chronic itch associated with these conditions. This biologic also stands out by offering four-week dosing intervals from the start of treatment, providing added convenience for patients.
This approval comes after positive results from the phase III ARCADIA and OLYMPIA clinical trial programs. In the ARCADIA trials, which focused on patients with atopic dermatitis, Nemluvio was shown to significantly improve skin clearance, reduce itching, and alleviate sleep disturbance in patients when administered subcutaneously every four weeks, combined with background topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI). The results demonstrated statistically significant improvements by Week 16 when compared to a placebo combination.
Similarly, the OLYMPIA trials, which focused on adults with prurigo nodularis, showed that Nemluvio, as monotherapy, provided significant and clinically meaningful improvements in skin lesions and itch reduction at Week 16. The trials also demonstrated quick relief of symptoms, with improvements in itching and sleep disturbance visible within four weeks of initiating treatment.
The safety profile of Nemluvio in these trials was consistent with earlier data and generally well tolerated, confirming its potential as a safe and effective treatment for patients suffering from these challenging dermatological conditions.
Professor Diamant Thaçi, the lead investigator of the ARCADIA studies in Europe, highlighted the significance of this approval, stating, “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 now have a new treatment option that has demonstrated efficacy in safely easing the key symptoms of these diseases.”
Professor Sonja Ständer, lead investigator of the OLYMPIA studies in Europe, added, “Nemolizumab’s benefits have been demonstrated in comprehensive clinical trials for both atopic dermatitis and prurigo nodularis. The clinical data, along with its first-in-class mechanism of action and convenient dosing schedule, make it an important new therapeutic option for dermatologists.”
Nemluvio has also been approved by the U.S. Food and Drug Administration for treating both atopic dermatitis and prurigo nodularis. The drug is currently under review by various regulatory authorities worldwide, including in Canada, Brazil, South Korea, Australia, Singapore, Switzerland, and through the Access Consortium framework. Galderma anticipates global expansion and further regulatory approvals in the coming months.
With expectations of reaching peak sales of over $2 billion USD, Galderma forecasts that Nemluvio will achieve “blockbuster” net sales by the end of 2027, solidifying its position as a key product in the company’s growth trajectory. The approval of Nemluvio marks an important step forward in dermatology, providing patients with a much-needed treatment option and reinforcing Galderma’s ongoing commitment to enhancing dermatologic care.
