FDA approval of nemolizumab gives new treatment option for prurigo nodularis

The FDA has approved nemolizumab-ilto (Nemluvio; Galderma) for treating prurigo nodularis, a chronic skin condition characterized by intensely itchy nodules. Nemolizumab is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31, a neuroimmune cytokine that drives multiple disease mechanisms in prurigo nodularis

The efficacy of nemolizumab was demonstrated in two pivotal phase 3 trials, OLYMPIA 1 and OLYMPIA 2. The key efficacy measures included the proportion of patients who achieved at least a 4-point reduction in itch intensity, the proportion with an Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear), and those who responded positively in both measures.

In OLYMPIA 1, 22% of patients treated with nemolizumab achieved both a significant reduction in itch intensity and an IGA score of 0 or 1, compared to just 2% of the placebo group. Additionally, 56% of nemolizumab patients saw a 4-point improvement in itch intensity and 32% had a Peak-Pruritus Numerical Rating Scale (PP-NRS) score of less than 2, compared to 16% and 4% in the placebo group, respectively.

OLYMPIA 2 yielded similar results, with 25% of nemolizumab patients achieving the combined itch and IGA outcome, compared to 4% of the placebo group. The study also showed that 49% of nemolizumab patients achieved at least a 4-point improvement in itch, and 31% had a PP-NRS score below 2, compared to 16% and 7% in the placebo group, respectively.

The most common adverse reactions reported with nemolizumab were headache, atopic dermatitis, eczema, and nummular eczema. This approval provides a promising new treatment option for those suffering from prurigo nodularis, addressing an unmet need in dermatology.

Disclosures: This article was created by the touchDERMATOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.