The FDA has approved Galderma's nemolizumab (Nemluvio) for the treatment of prurigo nodularis in adult patients.

Nemolizumab is the first monoclonal antibody approved for this indication that specifically targets interleukin (IL)-31, a key cytokine involved in itch, inflammation, abnormal skin differentiation, and fibrosis in prurigo nodularis, according to a press release from Galderma.

The approval was based on data from the phase III OLYMPIA 1 and OLYMPIA 2 clinical trials, which evaluated the safety and efficacy of nemolizumab in over 500 patients with prurigo nodularis. The co-primary endpoints were the proportion of patients achieving at least a 4-point reduction in the peak-pruritus numerical rating scale (PP-NRS) score and the proportion achieving an Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) at week 16.

Among the key findings of the trials were:

• 56% and 49% of the patients who received nemolizumab in the OLYMPIA 1 and OLYMPIA 2 trials, respectively, achieved a ≥ 4-point PP-NRS reduction vs 16% of the patients who received placebo (P < .001) at week 16.
• 41% of the patients in the nemolizumab group achieved a ≥ 4-point PP-NRS reduction at week 4 vs 6% to 7% of those in the placebo group (P < .001).
• 26% and 38% of the patients who received nemolizumab in the OLYMPIA 1 and OLYMPIA 2 trials, respectively, achieved an IGA score of 0 or 1 vs 7% and 11% of those who received placebo (P < .001) at week 16.
• 50% and 52% of the patients who received nemolizumab achieved a ≥ 4-point reduction in sleep disturbance NRS scores vs 12% and 21% of those who received placebo (P < .001) at week 16.

Nemolizumab was generally well-tolerated, with a safety profile consistent across the phase II and phase III trials. The most common adverse events were headaches and skin rashes (eczema, atopic dermatitis, and nummular eczema).

Galderma's marketing authorization applications for nemolizumab in prurigo nodularis and atopic dermatitis are currently under review by multiple regulatory authorities worldwide. The FDA has also accepted a biologics license application for nemolizumab in moderate-to-severe atopic dermatitis, with a decision anticipated later this year.