CHMP endorses Galderma's nemolizumab for atopic dermatitis and prurigo nodularis

The European Medicines Agency's human medicines committee has put forward a recommendation for the drug nemolizumab, developed by Galderma, to be used in treating two severe skin conditions: atopic dermatitis and prurigo nodularis. This recommendation extends to patients with moderate-to-severe forms of these conditions. Specifically, the Committee for Medicinal Products for Human Use (CHMP) has advised that nemolizumab be administered subcutaneously for treating atopic dermatitis in individuals aged 12 and older, as well as in adults dealing with prurigo nodularis. Importantly, candidates for this treatment should also be eligible for systemic therapy.

Atopic dermatitis is a prevalent condition in the European Union, affecting up to 40 million people. It is marked by severe itching and the presence of eczematous lesions. On the other hand, prurigo nodularis is less common, with an estimated 111 affected individuals per 100,000 in the EU, although this varies depending on the country. This condition is characterized by chronic itching and the formation of skin nodules.

Nemolizumab, which was initially developed by Chugai Pharmaceutical, functions by inhibiting the signaling of interleukin-31, a neuroimmune cytokine known to drive itching and contribute to inflammation and dysfunction in the skin barrier in these skin disorders. The recommendation by the CHMP for its use in treating atopic dermatitis was founded on the findings from the phase 3 ARCADIA 1 and 2 trials. These trials demonstrated that nemolizumab, when used in conjunction with topical corticosteroids, led to statistically significant improvements in primary and secondary endpoints compared to the placebo group after 16 weeks of treatment. Notably, significant relief from itching was observed as soon as the first week of treatment.

For prurigo nodularis, the committee's decision was supported by results from the late-stage OLYMPIA 1 and 2 trials. These trials successfully met their primary and key secondary endpoints, showing that nemolizumab treatment resulted in significant and clinically meaningful improvements in itching and the appearance of skin nodules by the 16th week, with noticeable reductions in itch starting from the fourth week.

Following the CHMP's recommendation, the European Commission (EC) is set to consider this guidance as part of its decision-making process regarding the approval of nemolizumab for these indications. Galderma's CEO, Flemming Ørnskov, expressed optimism about the potential impact of nemolizumab, emphasizing the strong evidence supporting its efficacy in improving outcomes for patients with these conditions. He highlighted the substantial burden and unmet needs associated with atopic dermatitis and prurigo nodularis, and expressed hope for the EC's approval to make nemolizumab available to patients across the EU soon.