Galderma’s Nemluvio® Approved in UK & Switzerland for Skin Conditions
Galderma, a global leader in dermatology, has announced that its innovative monoclonal antibody treatment, Nemluvio® (nemolizumab), has been granted marketing authorization by both the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Swissmedic, the Swiss regulatory authority. These approvals allow Nemluvio® to be prescribed for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis in the UK and Switzerland, respectively. This milestone represents a significant advancement in the management of these challenging dermatological conditions and highlights Galderma’s commitment to bringing innovative therapeutic solutions to patients worldwide.
Indications and Approved Use
The approval specifies that nemolizumab can be used subcutaneously for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors. This treatment is intended for adult and adolescent patients aged 12 years and older who weigh at least 30kg and are candidates for systemic therapy. Additionally, nemolizumab is now approved for the treatment of adults with moderate-to-severe prurigo nodularis who require systemic therapy.
Significance of the Approvals
These authorizations mark the first regulatory approvals of nemolizumab within the Access Consortium framework. The Access Consortium is an international collaboration of regulatory authorities that includes the UK, Switzerland, Australia, Canada, and Singapore. This partnership aims to streamline and enhance the regulatory process for new therapies. Regulatory decisions for nemolizumab in Australia and Singapore are anticipated later in the year. Furthermore, Nemluvio® has already received approval in the European Union and the United States for both atopic dermatitis and prurigo nodularis, reinforcing its role as a leading treatment option in dermatology.
The Burden of Atopic Dermatitis and Prurigo Nodularis
Atopic dermatitis and prurigo nodularis are chronic, debilitating skin conditions that significantly impact patients’ quality of life. In the UK, approximately 1.6 million individuals suffer from atopic dermatitis, while around 18,000 are affected by prurigo nodularis. In Switzerland, these conditions collectively affect around 450,000 people. Despite the availability of treatments, many patients continue to experience persistent symptoms, including severe itch, skin lesions, and disrupted sleep patterns, which contribute to emotional distress and impaired daily functioning.
One of the most distressing symptoms of both conditions is intense itching. Surveys indicate that 87% of patients with atopic dermatitis prioritize relief from itch as their primary treatment goal, while 88% of patients with prurigo nodularis consider itching their most severe symptom. These statistics highlight the urgent need for effective therapies that can alleviate these burdensome symptoms and improve patients’ overall well-being.
Expert Opinions on Nemolizumab’s Approval
Leading dermatologists have welcomed the approval of Nemluvio®, emphasizing its potential to transform the treatment landscape for atopic dermatitis and prurigo nodularis.
Dr. Curdin Conrad, Professor of Dermatology at Lausanne University Hospital in Switzerland, expressed enthusiasm for the newly approved therapy, stating:
“These approvals offer patients with moderate-to-severe atopic dermatitis and prurigo nodularis a much-needed novel treatment option, given the potential burden and negative impact on quality of life associated with these conditions. I am looking forward to offering my patients this new treatment option, which has the potential to address their most troublesome symptoms.”
Mechanism of Action: Targeting IL-31 for Effective Symptom Relief
Nemolizumab is the first monoclonal antibody specifically designed to target IL-31 receptor alpha, a key player in the neuroimmune pathway responsible for itch and inflammation. IL-31 is a cytokine that contributes to skin barrier dysfunction and inflammation in atopic dermatitis, as well as fibrosis in prurigo nodularis. By blocking IL-31 signaling, nemolizumab directly addresses the mechanisms that drive persistent itch and skin damage, offering patients significant symptom relief.
Clinical Trial Data Supporting Approval
The marketing authorization for Nemluvio® in the UK and Switzerland is based on compelling clinical evidence from two pivotal Phase III clinical trial programs: ARCADIA for atopic dermatitis and OLYMPIA for prurigo nodularis.
Findings from the ARCADIA Trials (Atopic Dermatitis)
The ARCADIA program assessed nemolizumab’s efficacy and safety in patients with moderate-to-severe atopic dermatitis. Key findings from these studies demonstrated that:
- Nemolizumab significantly improved skin lesions compared to placebo.
- Patients experienced a marked reduction in itching intensity, with improvements seen as early as the first few weeks of treatment.
- Sleep disturbance, a common issue among atopic dermatitis patients, was significantly alleviated, contributing to better overall quality of life.
- The treatment was well tolerated, with a safety profile consistent with prior clinical studies.
Findings from the OLYMPIA Trials (Prurigo Nodularis)
The OLYMPIA program evaluated nemolizumab in adults with moderate-to-severe prurigo nodularis, a condition characterized by intensely itchy, hard nodules on the skin. Results from these Galderma trials showed that:
- Nemolizumab led to significant and rapid itch reduction, a Galderma crucial benefit for patients suffering from this distressing condition Galderma .
- Patients experienced visible improvements in skin nodules Galderma and lesion healing.
- Sleep disturbances were significantly reduced, allowing for better rest and improved daytime functioning.
- Like the ARCADIA trials, nemolizumab was well tolerated, with no major safety concerns identified.
Galderma’s Commitment to Advancing Dermatological Therapies
Dr. Baldo Scassellati Sforzolini, Global Head of R&D at Galderma, emphasized the company’s dedication to advancing dermatological care and bringing innovative treatments to market. He stated:
“Nemolizumab’s continued regulatory success underscores Galderma’s strong leadership in Therapeutic Dermatology, and our commitment to bringing innovative treatments to patients. Its approval in the UK and Switzerland was driven yet again by robust data from the ARCADIA and OLYMPIA clinical trial programs, which show that nemolizumab has the potential to improve some of the most debilitating symptoms of both moderate-to-severe atopic dermatitis and prurigo nodularis.”
