The European Medicines Agency’s human medicines committee has recommended Galderma’s nemolizumab to treat atopic dermatitis and prurigo nodularis in patients with moderate-to-severe cases of the skin diseases.

The Committee for Medicinal Products for Human Use (CHMP) has recommended that nemolizumab be used subcutaneously to treat atopic dermatitis patients aged 12 years and older, and in adults with prurigo nodularis. Those eligible for the drug must also be candidates for systemic therapy, according to the recommendations.

Affecting up to 40 million people in the EU, atopic dermatitis is characterised by intense itch and eczematous lesions. The prevalence of prurigo nodularis, which causes chronic itch and skin nodules, is not well-documented, but it is estimated to affect up to 111 people per 100,000 in the EU depending on the country.

Initially developed by Chugai Pharmaceutical, nemolizumab is designed to inhibit signalling of the neuroimmune cytokine interleukin-31, which drives itch and is involved in inflammation and skin barrier dysfunction in both conditions.

The CHMP’s recommendation in atopic dermatitis was based on results from the phase 3 ARCADIA 1 and 2 trials, in which nemolizumab 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 committee’s decision in prurigo nodularis was supported by data from the late-stage OLYMPIA 1 and 2 trials, which met both their primary and key secondary endpoints, indicating that treatment with nemolizumab resulted in significant and clinically meaningful improvements in itch and skin nodules at week 16, with reductions in itch observed from week four.

The European Commission will now consider the CHMP’s recommendation as it makes a decision on nemolizumab in these indications.