Galderma's Nemluvio (nemolizumab) has received FDA approval for treating moderate-to-severe atopic dermatitis in patients aged 12 and older, marking a significant advancement in dermatological therapeutics. The approval, announced December 13, 2024, allows for the use of Nemluvio in conjunction with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when topical treatments alone are insufficient.
Nemolizumab, marketed as Nemluvio, is a monoclonal antibody and the first approved therapy specifically targeting the IL-31 receptor alpha. IL-31 is a neuroimmune cytokine known to drive itch and contribute to inflammation and epidermal dysregulation in atopic dermatitis. By blocking the signaling of IL-31, nemolizumab offers a targeted approach to alleviate key symptoms of the disease.
Clinical Efficacy
The FDA's decision was supported by data from the phase III ARCADIA clinical trial program, which involved 1,728 patients aged 12 years and older with moderate-to-severe atopic dermatitis. The trials compared nemolizumab in combination with background TCS, with or without TCI, against placebo with the same background therapies. Key findings from the ARCADIA program include:
- Significant improvements in skin clearance, measured by the Investigator's Global Assessment (IGA) score, were observed in patients treated with nemolizumab.
- A 75% reduction in the Eczema Area and Severity Index (EASI) score was achieved in a significant proportion of patients treated with nemolizumab compared to placebo.
- The trials also met key secondary endpoints, demonstrating significant itch relief as early as Week 1 and statistically significant improvements in sleep disturbance.
The safety profile of nemolizumab was consistent with that of the placebo group, with the drug being generally well-tolerated.
Expert Commentary
Professor Jonathan Silverberg, lead investigator of the ARCADIA clinical program and a professor of dermatology at George Washington University School of Medicine and Health Sciences, emphasized the impact of the approval. "Despite currently available treatment options, atopic dermatitis continues to have a massive impact worldwide, with patients not only burdened by intense itch and recurrent skin lesions, but also potentially several associated symptoms including sleep issues, pain, anxiety, and depression. I look forward to being able to offer this option to atopic dermatitis patients in my practice who are seeking relief from burdensome itch and lesions."
Market and Regulatory Landscape
Galderma anticipates peak sales of nemolizumab to exceed $2 billion, with expectations of achieving a 'blockbuster' net sales run-rate by the end of 2027. The FDA has also approved Nemluvio as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis in August 2024.
In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of nemolizumab for both atopic dermatitis and prurigo nodularis. Marketing authorization applications are also under review in other regions, including Australia, Singapore, Switzerland, Canada, Brazil, and South Korea.
