Galderma’s Nemluvio® (Nemolizumab) Approved for Atopic Dermatitis and Prurigo Nodularis in the UK and Switzerland
Galderma has announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Swissmedic have granted marketing authorization for Nemolizumab, a monoclonal antibody used to treat moderate-to-severe atopic dermatitis and prurigo nodularis. In the UK, Nemolizumab has been approved for subcutaneous use in combination with topical corticosteroids and/or calcineurin inhibitors for patients aged 12 years and older, with a body weight of at least 30kg, who are candidates for systemic therapy.
In Switzerland, the approval is for the treatment of adults with moderate-to-severe prurigo nodularis who also need systemic therapy. These approvals are significant as they represent the first from countries within the Access Consortium framework, which includes regulatory bodies that work together to address shared challenges. Decisions in other Access Consortium countries, such as Australia and Singapore, are expected later in the year.
Nemolizumab is also already approved in the European Union and the United States for the treatment of both moderate-to-severe atopic dermatitis and prurigo nodularis. Galderma’s leadership in therapeutic dermatology is underscored by these regulatory successes, reflecting the company’s commitment to delivering novel treatments to patients worldwide.
Atopic dermatitis and prurigo nodularis are two serious and debilitating skin conditions. In the UK, atopic dermatitis affects up to 1.6 million people, while prurigo nodularis affects around 18,000. In Switzerland, atopic dermatitis impacts 450,000 people, with prurigo nodularis also causing significant suffering. These conditions are characterized by persistent itching, skin lesions, and poor sleep quality, with itch being one of the most troublesome symptoms. A survey found that 87% of patients with atopic dermatitis and 88% of those with prurigo nodularis consider itch to be their worst symptom. The need for new and effective treatments is crucial for improving quality of life for patients suffering from these conditions.
Dr. Curdin Conrad, Professor of Dermatology at Lausanne University Hospital in Switzerland, emphasized the importance of Nemolizumab’s approval, stating that it provides a much-needed treatment option for patients facing the challenges of moderate-to-severe atopic dermatitis and prurigo nodularis. This approval brings hope to patients who need a new way to manage their symptoms and improve their daily lives.
Nemolizumab works by targeting and inhibiting the IL-31 receptor alpha, a neuroimmune cytokine that plays a critical role in driving itch, inflammation, and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis. Additionally, IL-31 is involved in the fibrosis associated with prurigo nodularis. By blocking the signaling of IL-31, Nemolizumab offers a novel therapeutic approach that directly addresses one of the most distressing symptoms of these conditions—persistent itching.
The approval of Nemolizumab in the UK and Switzerland is based on the positive results from two phase III clinical trial programs—ARCADIA and OLYMPIA. These trials demonstrated that Nemolizumab significantly improved symptoms such as skin lesions, itch, and sleep disturbance in patients with atopic dermatitis and prurigo nodularis. Both trials showed that the treatment was well-tolerated by patients, with a safety profile consistent with earlier data, ensuring its potential as a safe and effective option for those in need.
Dr. Baldo Scassellati Sforzolini, Global Head of Research and Development at Galderma, highlighted that the approval in the UK and Switzerland further underscores Galderma’s leadership in dermatology. He noted that the robust clinical data from the ARCADIA and OLYMPIA trials support Nemolizumab’s ability to provide relief for some of the most debilitating symptoms of moderate-to-severe atopic dermatitis and prurigo nodularis. Galderma is committed to bringing innovative treatments to patients and furthering its research in therapeutic dermatology.
Galderma itself is a leader in the dermatology market, operating in approximately 90 countries worldwide. The company focuses on delivering science-based solutions through a broad portfolio that spans Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since its founding in 1981, Galderma has dedicated itself to advancing dermatology and meeting the needs of patients and consumers alike. With its innovative approach and commitment to improving skin health, Galderma is advancing dermatology for every skin story.
The approval of Nemolizumab in the UK and Switzerland marks a significant milestone in the treatment of atopic dermatitis and prurigo nodularis. With its potential to address the most challenging symptoms of these conditions, Nemolizumab offers new hope for patients who have been waiting for effective solutions.
