Recurrent Skin Carcinoma

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Galderma’s Nemluvio (nemolizumab) to treat both atopic dermatitis and prurigo nodularis. The UK regulator has specifically approved the drug to treat atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents aged 12 years and older with a body weight of at least 30kg and for adults with prurigo nodularis. Eligible patients must also have moderate-to-severe cases of the skin diseases and be candidates for systemic therapy. Atopic dermatitis, characterised by persistent itch and recurrent skin lesions, affects up to 1.6 million people in the UK, while prurigo nodularis, which causes intense itch and thick skin nodules, affects approximately 18,000 people in the UK. Despite available treatments, Galderma said there is a need for new options to effectively relieve the signs and symptoms of both conditions. Nemluvio, which was initially developed by Chugai Pharmaceutical and administered as a subcutaneous injection every four weeks, is designed to inhibit signalling of the neuroimmune cytokine interleukin-31, which drives itch and is involved in inflammation and skin barrier dysfunction. The MHRA’s decision comes shortly after the European Commission authorised Nemluvio for both conditions and makes the drug the first approved monoclonal antibody in the UK that specifically targets interleukin-31 receptor alpha. The approval in atopic dermatitis was based on results from the late-stage ARCADIA 1 and 2 studies, in which Nemluvio in combination with background topical corticosteroids (TCS) was associated with statistically significant improvements in the co-primary and key secondary endpoints compared to placebo plus TCS after 16 weeks of treatment, with significant itch relief observed from as early as week one. The authorisation in prurigo nodularis was supported by data from the phase 3 OLYMPIA 1 and 2 trials, which met both primary and key secondary endpoints, demonstrating that treatment with Nemluvio resulted in significant and clinically meaningful improvements in itch and skin nodules at week 16, with reductions in itch observed from week four. Baldo Scassellati Sforzolini, global head of research and development at Galderma, said: “[Nemluvio’s] approval in the UK… was driven yet again by robust data from the ARCADIA and OLYMPIA clinical trial programmes, which show that [it] has the potential to improve some of the most debilitating symptoms of both moderate-to-severe atopic dermatitis and prurigo nodularis.”

The European Commission (EC) has approved Galderma’s Nemluvio (nemolizumab) to treat both atopic dermatitis and prurigo nodularis. The drug has been authorised for use in atopic dermatitis patients aged 12 years and older, and adults with prurigo nodularis. Eligible patients must also have moderate-to-severe cases of the skin diseases and be candidates for systemic therapy. Atopic dermatitis, characterised by persistent itch and recurrent skin lesions, affects up to 40 million people in the EU, with up to 66% of adults experiencing moderate-to-severe forms of the condition. Meanwhile, prurigo nodularis, which causes intense itch and thick skin nodules, is estimated to affect up to 111 people per 100,000 in the EU depending on the country. Despite available treatments, Galderma said there is a need for new options to effectively relieve the signs and symptoms of both conditions. Initially developed by Chugai Pharmaceutical and administered as a subcutaneous injection every four weeks, Nemluvio is designed to inhibit signalling of the neuroimmune cytokine interleukin-31, which drives itch and is involved in inflammation and skin barrier dysfunction. The EC’s decision comes two months after the European Medicines Agency’s human medicines committee recommended Nemluvio for both indications and makes the drug the first approved monoclonal antibody that specifically targets interleukin-31 receptor alpha. The approval in atopic dermatitis was based on results from the late-stage ARCADIA 1 and 2 studies, in which Nemluvio in combination with background topical corticosteroids (TCS) was associated with statistically significant improvements in the co-primary and key secondary endpoints compared to placebo plus TCS after 16 weeks of treatment, with significant itch relief observed from as early as week one. The authorisation in prurigo nodularis was supported by data from the phase 3 OLYMPIA 1 and 2 trials, which met both primary and key secondary endpoints, demonstrating that treatment with Nemluvio resulted in significant and clinically meaningful improvements in itch and skin nodules at week 16, with reductions in itch observed from week four. Lead investigator of the ARCADIA studies in Europe, Diamant Thaçi, University of Lubeck, said: “Atopic dermatitis and prurigo nodularis can severely impact quality of life due to the associated debilitating symptoms… With this approval, patients in the EU have a new treatment option, which extensive data has shown can help to safely, quickly and effectively ease the key symptoms of these diseases and therefore the burden on patients’ lives.”

WEDNESDAY, Dec. 18, 2024 -- The U.S. Food and Drug Administration has approved Nemluvio (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older. The approval is for use in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. Nemluvio is the first approved monoclonal antibody that targets interleukin-31 receptor alpha, which drives itch and is involved in inflammation and epidermal dysregulation in atopic dermatitis. The approval is based on the results of the phase 3 ARCADIA clinical trial program that included 1,728 patients aged 12 years and older with moderate-to-severe atopic dermatitis. After 16 weeks, patients treated with Nemluvio, administered subcutaneously every four weeks, in combination with TCS (with or without TCI) had statistically significant improvements on skin clearance (either clearance or almost-clearance using the Investigator's Global Assessment score). Patients also achieved a 75 percent reduction in the Eczema Area and Severity Index versus placebo in combination with TCS (with or without TCI), after 16 weeks of treatment. All key secondary end points were met, including significant responses on itch as early as week 1 and statistically significant improvements in sleep disturbance. Overall, Nemluvio was well tolerated, with similar safety profiles observed in both the Nemluvio and placebo groups. "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," lead investigator of the ARCADIA trial, Jonathan Silverberg, M.D., Ph.D., from George Washington University in Washington, D.C., said in a statement. "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." Approval of nemolizumab was granted to Galderma. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.