EU Approves Galderma's Nemluvio® for Severe Atopic Dermatitis and Prurigo Nodularis

On February 14, 2025, Galderma, a leading dermatology company based in Zug, Switzerland, announced a significant milestone with the European Commission's approval of Nemluvio. This newly approved treatment is intended for individuals suffering from moderate-to-severe atopic dermatitis and prurigo nodularis across the European Union. The approval grants permission for its subcutaneous application in patients 12 years and older who are eligible for systemic therapy for atopic dermatitis, as well as for adults with prurigo nodularis.

Nemluvio distinguishes itself as the first monoclonal antibody specifically targeting the IL-31 receptor alpha, a crucial component involved in the signaling pathway of IL-31. IL-31 is a neuroimmune cytokine that contributes to the itch sensation, inflammation, and skin barrier issues seen in both atopic dermatitis and prurigo nodularis. The treatment is unique as the only biologic approved with a four-week dosing interval right from the beginning of the therapy.

The approval was granted following successful results from the phase III ARCADIA and OLYMPIA clinical trial programs. These trials demonstrated Nemluvio's efficacy in significantly improving symptoms such as itch, skin lesions, and sleep disturbances in patients with moderate-to-severe atopic dermatitis and adults with prurigo nodularis, respectively.

In the ARCADIA 1 and ARCADIA 2 trials, patients receiving Nemluvio every four weeks, alongside topical corticosteroids and possibly topical calcineurin inhibitors, showed remarkable improvements in skin clearance by Week 16 compared to the placebo group. Key secondary endpoints, including the reduction of itch as early as Week 1 and improvements in sleep, were also met.

Similarly, the OLYMPIA 1 and OLYMPIA 2 trials confirmed significant improvements in itch and skin lesions for those treated with Nemluvio compared to placebo, hitting all primary and secondary endpoints. The rapid onset of relief from prurigo nodularis symptoms was evident within four weeks of treatment beginning.

Safety has been a critical component, and Nemluvio was well tolerated across all trials. Its safety profile remained consistent with previous data and across various studies. The U.S. Food and Drug Administration has also approved Nemluvio for treating both atopic dermatitis and prurigo nodularis. Moreover, regulatory review is ongoing in countries such as Canada, Brazil, and South Korea, and through the Access Consortium in regions including Australia, Singapore, and Switzerland.

The market potential for Nemluvio is substantial, with peak sales expected to exceed 2 billion USD in the future. Galderma aims for the drug to reach a 'blockbuster' sales status by the year 2027.

Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd., and in 2016, Galderma acquired the global rights, excluding Japan and Taiwan, where it is marketed as Mitchga. In Japan, it is approved for treating prurigo nodularis and pruritus linked to atopic dermatitis for a wide range of age groups.

The ARCADIA clinical trial program involved two pivotal phase III trials, enrolling over 1,700 patients, to evaluate Nemluvio's safety and efficacy for moderate-to-severe atopic dermatitis. These trials included adolescent and adult patients for an initial treatment phase of 16 weeks, with successful patients entering a maintenance phase for up to 48 weeks.

Meanwhile, the OLYMPIA clinical trial program, the largest for prurigo nodularis, assessed the efficacy and safety of Nemluvio in patients aged 18 and older. Both the 16-week and 24-week treatment periods of these trials confirmed Nemluvio’s potential to significantly alleviate the symptoms of this debilitating condition.