Galderma has submitted Biologics License Applications (BLAs) for nemolizumab for the treatment of prurigo nodularis (PN) and for moderate to severe atopic dermatitis (AD) in adolescents and adults. Nemolizumab is a first-in-class investigational monoclonal antibody specifically designed to inhibit IL-31 signaling.
The U.S. FDA has granted nemolizumab Priority Review for the treatment of prurigo nodularis. The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab in both prurigo nodularis and atopic dermatitis. Galderma is planning for multiple regulatory submissions in 2024.
The FDA submissions of nemolizumab in prurigo nodularis are based on data from the phase 3 OLYMPIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks. In the OLYMPIA program, patients treated with nemolizumab monotherapy showed clinically and statistically significant improvements in both primary endpoints compared to placebo after 16 weeks of treatment. More than half of nemolizumab-treated patients achieved an at least four-point reduction in itch intensity, as measured by the peak-pruritus numerical rating scale. On average, a third of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment (IGA) score.
The trials also met all key secondary endpoints confirming rapid onset of action on itch and sleep disturbance in PN within four weeks of treatment initiation, Galderma says.
The regulatory submissions of nemolizumab in atopic dermatitis are based on data from the phase 3 ARCADIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks in adolescents and adults. Both ARCADIA trials showed clinically and statistically significant improvements in co-primary endpoints, compared to placebo, after 16 weeks of treatment. More than a third of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions when assessed using the IGA score. More than 40% of nemolizumab-treated patients achieved a 75% reduction in the Eczema Area and Severity Index.
The trials also met all key secondary endpoints in AD, confirming rapid onset of action on itch and sleep disturbance, with statistically significant and clinically meaningful improvements observed as early as one week after treatment initiation.
Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 worldwide, except Japan and Taiwan. In Japan, nemolizumab is approved for the treatment of pruritus associated with atopic dermatitis and is in development for prurigo nodularis.