Galderma set to change lives with new treatment for severe skin diseases in Europe

In December 2024, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion regarding Nemolizumab, a monoclonal antibody developed by Galderma for treating moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union. This decision aligns with the trend toward addressing chronic inflammatory skin diseases, which affect millions across Europe. A significant number of adults suffer from moderate-to-severe conditions, with many seeking relief from persistent itch and skin lesions. The positive recommendation follows a successful phase III clinical trial program known as ARCADIA, which provided robust efficacy and safety data for Nemolizumab. Over 1,700 participants, including adolescents and adults, were involved in the study, where treatment showed marked improvement in their symptoms. Notably, reductions in itch were noticeable as early as four weeks into treatment, highlighting the potential benefits of a timely intervention for patients suffering from these debilitating skin conditions. Atopic dermatitis and prurigo nodularis are both chronic diseases that can severely impact quality of life, not only causing physical discomfort but also contributing to mental health issues due to their persistent and often socially stigmatized symptoms. The need for effective therapies is pressing, as many patients report inadequate results from existing treatments. Nemolizumab targets the IL-31 receptor alpha to inhibit signaling involved in itch and inflammation, addressing the root cause of these conditions. The CHMP's recommendation is a key milestone for Galderma and could lead to the first specific monoclonal antibody treatment available in the EU for these serious skin conditions. Following this opinion, the recommendation will be forwarded to the European Commission for a final marketing authorization decision, which would enable patients to access a new therapeutic option significantly improving their quality of life.