Nemluvio Approved in EU for Atopic Dermatitis and Prurigo Nodularis

Galderma announced that the European Commission has approved Nemluvio for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio is now approved for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31. IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis, and fibrosis in prurigo nodularis. It is also the first and only biologic approved for atopic dermatitis and prurigo nodularis with four-week dosing intervals from the start of treatment.

This approval is based on results from the phase III ARCADIA and OLYMPIA clinical trial programs, in which Nemluvio significantly improved itch, skin lesions and sleep disturbance, in patients with moderate-to-severe atopic dermatitis and adults with prurigo nodularis, respectively.

Results from the ARCADIA 1 and ARCADIA 2 trials demonstrated that patients treated with Nemluvio, administered subcutaneously every four weeks in combination with background topical corticosteroids, with or without topical calcineurin inhibitors (+TCS/TCI), showed statistically significant improvements on skin clearance in both co-primary endpoints at Week 16, when compared to placebo +TCS/TCI. The trials also met all key secondary endpoints, confirming significant responses on itch as early as Week 1 and statistically significant improvements in sleep disturbance.

Both co-primary endpoints were also met in the OLYMPIA 1 and OLYMPIA 2 clinical trials, where Nemluvio monotherapy demonstrated significant and clinically meaningful improvements on itch and skin lesions at Week 16, when compared to placebo. The trials met all key secondary endpoints, showing rapid reduction in itch due to prurigo nodularis and sleep disturbance within four weeks of treatment initiation.

Nemluvio was well tolerated in all trials, and its safety profile was generally consistent with earlier data, and between trials.

Nemluvio is also approved by the U.S. Food and Drug Administration for the treatment of atopic dermatitis and prurigo nodularis. It is under review for the treatment of both diseases by several additional regulatory authorities around the world, including Canada, Brazil, and South Korea, and via the Access Consortium framework in countries such as Australia, Singapore and Switzerland. Further submissions to other regulatory authorities are ongoing.

As previously communicated, peak sales of Nemluvio are expected to reach more than 2 billion USD (expected beyond the 2023-2027 mid-term guidance period). Galderma anticipates Nemluvio to approach ‘blockbuster’ net sales run-rate by the end of 2027.