EC Approves Nemluvio for Atopic Dermatitis and Prurigo Nodularis

The European Commission has given its approval for Galderma's innovative medication, Nemluvio (nemolizumab), to be used in the treatment of both atopic dermatitis and prurigo nodularis. This decision marks a noteworthy advancement in the management of these challenging skin conditions. Nemluvio is now authorized for use in patients aged 12 and older who suffer from atopic dermatitis, as well as adults diagnosed with prurigo nodularis. It is specifically indicated for those experiencing moderate-to-severe forms of these diseases and who are suitable candidates for systemic therapy.

Atopic dermatitis is a condition that manifests through persistent itching and recurrent skin lesions, affecting up to 40 million individuals across the European Union. Of these, approximately 66% endure moderate-to-severe forms of the condition, which significantly impacts their quality of life. On the other hand, prurigo nodularis is characterized by intense itching and the development of thick skin nodules. This condition is estimated to affect up to 111 people per 100,000 in certain regions within the EU.

Despite existing treatment options, there remains a substantial need for new methodologies to alleviate the symptoms and signs of both atopic dermatitis and prurigo nodularis effectively. Nemluvio, initially developed by Chugai Pharmaceutical, represents a promising solution. Administered as a subcutaneous injection every four weeks, the drug functions by inhibiting the signaling of the neuroimmune cytokine interleukin-31. This cytokine plays a critical role in driving itch and is implicated in inflammation and the dysfunction of the skin barrier.

The European Commission's approval comes shortly after the European Medicines Agency's human medicines committee recommended the drug for both conditions. This makes Nemluvio the first monoclonal antibody approved to specifically target the interleukin-31 receptor alpha, a significant breakthrough in dermatological treatment.

The approval for treating atopic dermatitis was grounded in the positive outcomes from the late-stage ARCADIA 1 and 2 studies. In these studies, Nemluvio, when used in conjunction with background topical corticosteroids (TCS), led to statistically significant improvements in both co-primary and key secondary endpoints compared to a placebo with TCS over a 16-week treatment period. Notably, significant itch relief was observed as early as the first week of treatment.

For prurigo nodularis, the authorisation was supported by data from the phase 3 OLYMPIA 1 and 2 trials. These trials successfully met both primary and key secondary endpoints, demonstrating significant and clinically meaningful improvements in itch and reduction of skin nodules by the 16th week of treatment, with reductions in itch noticeable from the fourth week.

Diamant Thaçi, the lead investigator of the ARCADIA studies in Europe from the University of Lubeck, emphasized the profound impact of these conditions on patients' lives due to their debilitating symptoms. He noted that with this approval, patients in the EU now have access to a new treatment option backed by extensive data, which can help alleviate the key symptoms of these diseases efficiently. This development is expected to significantly reduce the burden on patients and enhance their quality of life.