Nemolizumab Approved for AD, Prurigo Nodularis in Europe

The European Commission has approved nemolizumab (Nemluvio) for subcutaneous use in treating moderate to severe atopic dermatitis (AD) in patients aged ≥ 12 years and moderate to severe prurigo nodularis in adults, according to the manufacturer Galderma. Those eligible must be candidates for systemic therapy.

The announcement on February 14 marks the first approval for a monoclonal antibody that specifically blocks the signaling of interleukin (IL)-31. IL-31 is a protein that drives itch and plays a role in inflammation and skin barrier dysfunction in both AD and prurigo nodularis and fibrosis in prurigo nodularis, the company states.

Nemolizumab “is also the first and only biologic approved for atopic dermatitis and prurigo nodularis with 4-week dosing intervals from the start of treatment,” according to the statement.

Nemolizumab was approved by the US Food and Drug Administration for both AD and prurigo nodularis in 2024 and is under review by several additional regulatory authorities globally.

Approval from the European Commission is based on phase 3 results of the randomized, double-blind ARCADIA and OLYMPIA clinical trials, in patients with moderate to severe AD and those with prurigo nodularis, respectively, which showed that treatment with nemolizumab is effective in relieving persistent symptoms such as itch, skin lesions, and poor sleep.

For AD, results from the ARCADIA 1 and ARCADIA 2 trials demonstrated that nemolizumab, administered subcutaneously every 4 weeks with topical corticosteroids, with or without topical calcineurin inhibitors (TCS/TCI), showed statistically significant skin clearance in key endpoints at week 16 compared with placebo plus TCS/TCI. 

Significantly more patients receiving nemolizumab vs placebo achieved Investigator’s Global Assessment success in both ARCADIA 1 (36% vs 25%; P = .0003) and ARCADIA 2 (38% vs 26%; P = .0006).

Eczema Area and Severity Index 75 response rates were also significantly higher with nemolizumab compared with the placebo group in both trials: ARCADIA 1 (44% vs 29%; P P = .0006)

The trials also met all key secondary endpoints, demonstrating significant itch relief by the first week and statistically significant improvements in sleep disturbance, the company stated.

Both co-primary endpoints were also met in the ongoing OLYMPIA 1 and OLYMPIA 2 trials, where nemolizumab alone demonstrated significant and clinically meaningful improvements on itch and skin lesions at week 16, compared with placebo, in patients with prurigo nodularis. The trials met all key secondary endpoints, showing rapid relief from prurigo nodularis itch and sleep disturbance within one month of treatment start.

More than 80% of nemolizumab-treated patients with prurigo nodularis experienced improvement in itch, and more than 60% achieved clear or almost-clear skin, according to 1-year data from an interim analysis of the OLYMPIA long-term extension study presented at the American Academy of Dermatology 2024 meeting.

Nemolizumb “was well tolerated in all trials, and its safety profile was generally consistent with earlier data and between trials,” the manufacturer states.

Marcia Frellick is an independent healthcare journalist based in Chicago.