The European Commission (EC) has approved Galderma’s Nemluvio (nemolizumab) to treat both atopic dermatitis and prurigo nodularis.
The drug has been authorised for use in atopic dermatitis patients aged 12 years and older, and adults with prurigo nodularis. Eligible patients must also have moderate-to-severe cases of the skin diseases and be candidates for systemic therapy.
Atopic dermatitis, characterised by persistent itch and recurrent skin lesions, affects up to 40 million people in the EU, with up to 66% of adults experiencing moderate-to-severe forms of the condition. Meanwhile, prurigo nodularis, which causes intense itch and thick skin nodules, is estimated to affect up to 111 people per 100,000 in the EU depending on the country.
Despite available treatments, Galderma said there is a need for new options to effectively relieve the signs and symptoms of both conditions.
Initially developed by Chugai Pharmaceutical and administered as a subcutaneous injection every four weeks, Nemluvio is designed to inhibit signalling of the neuroimmune cytokine interleukin-31, which drives itch and is involved in inflammation and skin barrier dysfunction.
The EC’s decision comes two months after the European Medicines Agency’s human medicines committee recommended Nemluvio for both indications and makes the drug the first approved monoclonal antibody that specifically targets interleukin-31 receptor alpha.
The approval in atopic dermatitis was based on results from the late-stage ARCADIA 1 and 2 studies, in which Nemluvio in combination with background topical corticosteroids (TCS) was associated with statistically significant improvements in the co-primary and key secondary endpoints compared to placebo plus TCS after 16 weeks of treatment, with significant itch relief observed from as early as week one.
The authorisation in prurigo nodularis was supported by data from the phase 3 OLYMPIA 1 and 2 trials, which met both primary and key secondary endpoints, demonstrating that treatment with Nemluvio resulted in significant and clinically meaningful improvements in itch and skin nodules at week 16, with reductions in itch observed from week four.
Lead investigator of the ARCADIA studies in Europe, Diamant Thaçi, University of Lubeck, said: “Atopic dermatitis and prurigo nodularis can severely impact quality of life due to the associated debilitating symptoms… 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 the burden on patients’ lives.”