Nemluvio (nemolizumab-ilto) / Roche, Maruho, Galderma - LARVOL DELTA

Galderma Delivers Record First Quarter Net Sales of 1.129 Billion USD, Including Strong Performance From Two Launches With Blockbuster Potential, and Confirms Full-Year Guidance (Businesswire) - "Therapeutic Dermatology net sales for the first quarter of 2025 were 212 million USD, with year-on-year growth of 4.9% on a constant currency basis....Nemluvio delivered 39 million USD in sales, driven by strong initial uptake across both prurigo nodularis and atopic dermatitis in the U.S., as well as initial International sales from its launch in Germany."

Sales • Atopic Dermatitis • Prurigo Nodularis

Clinical factors predicting nemolizumab response in atopic dermatitis. (PubMed, J Allergy Clin Immunol Glob) - "While serum IgE levels and baseline Eczema Area Severity Index (EASI) scores alone were not predictive, their combination with disease duration improved discrimination between responders and nonresponders. Disease duration, serum IgE levels, and baseline EASI scores can be useful to predict nemolizumab efficacy in AD."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Chronic Pruritus: A Review of Its Pathophysiology and Current Treatments (PubMed, Rev Med Chil) - "A stepped pharmacological approach, tailored to the individual symptomatology of each patient, facilitates the treatment of chronic pruritus. Although progress has been made in understanding the pathophysiology and pharmacology associated with pruritus management, this symptom still requires further national epidemiological studies to determine its prevalence and to objectively assess its impact on the quality of life of affected individuals."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • TSLP

Effectiveness and Safety of Nemolizumab in Patients with Prurigo Nodularis: a Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Clin Rev Allergy Immunol) - "While these findings are promising, the small number of included studies and potential for publication bias warrant cautious interpretation and highlight the need for further research. These findings support its role as a promising option for individuals with PN who are unresponsive to standard therapies."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Dermatology • Immunology • Inflammation • Prurigo Nodularis • Pruritus • Sleep Disorder

Psychometric Validation of the Subject Sleep Diary in Patients with Moderate-to-Severe Atopic Dermatitis. (PubMed, Dermatol Ther (Heidelb)) - P3 | "The results provided evidence that the SSD, particularly its SOL, WASO, TWASO, TWT, SE, NWASO-AD, WASO-AD, and SQR parameters, is reliable and valid to measure multidimensional concepts of sleep disturbance in clinical studies."

Journal • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Pruritus • Sleep Disorder

Rapid Clinical Response to Nemolizumab in Dermatologic Diseases Associated with Pruritus and Burning: A Multicenter Case Series. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Amyloidosis • Atopic Dermatitis • Cutaneous T-cell Lymphoma • Dermatitis • Dermatology • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Mycosis Fungoides • Neuralgia • Oncology • Pain • Pruritus • Rare Diseases • Rosacea • Urticaria

Long-term (68 weeks) administration of nemolizumab and topical corticosteroids for prurigo nodularis in patients aged ≥13 years: efficacy and safety data from a phase II/III study. (PubMed, Br J Dermatol) - "Nemolizumab elicited continuous and durable improvements across multiple measures of pruritus, PN severity, and quality of life over 68 weeks of treatment, with no new safety concerns. (Funded by Maruho; jRCT number, 2011200017)."

Journal • P2/3 data • CNS Disorders • Dermatology • Immunology • Insomnia • Prurigo Nodularis • Pruritus • Sleep Disorder

A Case of Erythema Multiforme Following the Administration of Nemolizumab. (PubMed, Cureus) - "To our knowledge, this may be the first reported case of EM following nemolizumab treatment for PN. Further research is necessary to investigate its immunomodulatory effects and potential adverse events."

Journal • Dermatology • Immunology • Infectious Disease • Inflammation • Prurigo Nodularis • IL13 • IL5

Breaking the Itch Cycle: Long-Term effects of Nemolizumab in Prurigo Nodularis. (PubMed, Br J Dermatol) - No abstract available

Journal • Immunology • Prurigo Nodularis

Efficacy and Safety of Nemolizumab in Patients With Prurigo Nodularis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Cureus) - "Despite these limitations, the findings suggest that nemolizumab is an effective and well-tolerated treatment for prurigo nodularis. Further research with longer follow-up periods and larger, more diverse patient populations is recommended to establish the long-term efficacy and safety profile of nemolizumab in treating this condition."

Journal • Retrospective data • Review • Immunology • Prurigo Nodularis

Emerging treatments for dermatologic diseases in infants, children, and adolescents: a systematic review of clinical trials on biologics and small molecule inhibitors. (PubMed, Inflammopharmacology) - "Biologics and SMIs show great promise as therapeutic options in paediatric dermatology, offering better efficacy compared to traditional treatments. Despite these encouraging findings, additional research is needed to verify their long-term safety, especially in relation to growth and development in younger patients. Future investigations should aim to include a broader range of patient demographics and dermatological conditions beyond those currently studied."

Journal • Review • Alopecia • ANCA Vasculitis • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics • Psoriasis • Urticaria • Vasculitis

Continuous response with nemolizumab up to 56 weeks during a long-term extension study in patients with moderate-to-severe atopic dermatitis and partial or delayed skin response at Week 16 – Post-hoc analyses from the pooled ARCADIA 1&2 trials and long-term extension study (AAD 2025) - P3 | "While some participants with moderate-to-severe AD receiving nemolizumab may experience a delayed skin response, continued nemolizumab treatment with optional TCS/TCI may still lead to a meaningful clinical outcome in a longer term."

Clinical • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus

Emerging Immunomodulatory Treatments for Pediatric Atopic Dermatitis: A Systematic Review (AAD 2025) - "Dupilumab additionally reduced the risk of atopic march (HR 0.68), asthma (HR 0.60), and allergic rhinitis (HR 0.69). Abrocitinib showed a 72.0% improvement in EASI-75 (p < 0.05). Emerging immunomodulatory agents offer promising new options for treating pediatric AD, demonstrating significant improvements in disease severity and potentially reducing long-term comorbidities."

Clinical • Immunomodulating • Review • Allergic Rhinitis • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pediatrics • Respiratory Diseases

Characterization of the pruriginous lesion types in individuals with prurigo nodularis and efficacy from the randomized, placebo-controlled, Phase 3 OLYMPIA 1&2 trials (AAD 2025) - P3 | "This analysis shows that nemolizumab has an effect on all pruriginous lesion types in addition to its efficacy in reducing nodules."

Clinical • P3 data • Dermatology • Immunology • Prurigo Nodularis

Galderma’s Nemluvio (Nemolizumab) Granted Marketing Authorization in the United Kingdom and Switzerland for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis (BioSpace) - "Galderma today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency and Swissmedic have granted the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the UK and Switzerland, respectively....This approval is based on robust results from the phase III ARCADIA and OLYMPIA clinical trial programs..."

EMA approval • MHRA approval • Atopic Dermatitis • Prurigo Nodularis

Severe Atopic Dermatitis With Increasing Daytime Sleepiness Following Nemolizumab Administration: A Case Report. (PubMed, Cureus) - "Therefore, careful monitoring of both dermatologic outcomes and daytime vigilance is essential. Clinicians should be aware of potential post-injection sleepiness when administering nemolizumab, given that it is an otherwise effective treatment for severe AD."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • Sleep Disorder • Sleep Wake Cycle Disorder

AAD 2025: Galderma to Present Extensive Updates From Across Its Dermatology Portfolio, Demonstrating Its Category Leadership and Strong Momentum (Businesswire) - "Galderma will present updates from across its broad dermatology portfolio at the 2025 American Academy of Dermatology (AAD) Annual Meeting, taking place from March 7-11, 2025 in Orlando, Florida....New data on Nemluvio reinforce its benefit for a broad range of patients with prurigo nodularis and atopic dermatitis. An oral presentation will report new data on the efficacy of Nemluvio treatment up to Week 16 across different pruriginous lesion types in patients with prurigo nodularis from the phase III OLYMPIA program. This will be presented on Friday, March 7. The company will also share data demonstrating the continuous response with Nemluvio up to 56 weeks in patients with moderate-to-severe atopic dermatitis who had a partial or no response to treatment at Week 16 in the ARCADIA 1&2 trials and long-term extension study."

P3 data • Atopic Dermatitis • Prurigo Nodularis

Immediate and sustained efficacy of nemolizumab in chronic pruritus of unknown origin. (PubMed, J Dermatol) - No abstract available

Journal • Dermatology • Pruritus

Executive summary: Japanese guidelines for atopic dermatitis (ADGL) 2024. (PubMed, Allergol Int) - "To achieve this, topical anti-inflammatory drugs such as topical corticosteroids, tacrolimus ointment, delgocitinib ointment, and difamilast ointment have been used. However, the following treatments should be considered in addition to topical therapy for patients with refractory moderate-to-severe AD: oral cyclosporine, subcutaneous injections of biologics (dupilumab, nemolizumab, tralokinumab), oral Janus kinase inhibitors (baricitinib, upadacitinib, abrocitinib), and phototherapy. In the revised guidelines, descriptions of five new drugs, namely, difamilast, nemolizumab, tralokinumab, upadacitinib, and abrocitinib, have been added. The guidelines present recommendations to review clinical research articles, evaluate the balance between the advantages and disadvantages of medical activities, and optimize medical activity-related patient outcomes with respect to several important points requiring decision-making in clinical practice."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus

Galderma’s Nemluvio (Nemolizumab) Approved in the European Union for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis (Businesswire) - "Galderma...today announced that the European Commission has approved Nemluvio for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio is now approved for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy...This approval is based on results from the phase III ARCADIA and OLYMPIA clinical trial programs, in which Nemluvio significantly improved itch, skin lesions and sleep disturbance, in patients with moderate-to-severe atopic dermatitis and adults with prurigo nodularis, respectively."

EMA approval • Atopic Dermatitis • Prurigo Nodularis

Nemolizumab (Nemluvio) for atopic dermatitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Comparison chart: Interleukin (IL) receptor antagonists for atopic dermatitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Clinical Factors Predicting Nemolizumab Response in Atopic Dermatitis (AAAAI-WAO 2025) - "Additionally, receiver operating characteristic curve (ROC) analysis revealed that baseline EASI scores, disease duration, and serum IgE levels demonstrated high diagnostic accuracy in distinguishing between responders and non-responders, with AUCs of 0.883, 0.958, and 0.896, respectively. Conclusions Taken together, we propose baseline EASI scores, disease duration, and serum IgE levels are potentially useful parameters for identifying non-responders to nemolizumab in AD patients."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Chugai Announces Consolidated 2024 Full Year Results and Forecasts for 2025 (Chugai Press Release) - "In the specialty field, sales decreased by 28.3% compared with previous year, mainly due to the completion of supply of Ronapreve to the government, despite that our new product Vabysmo grew and our mainstay products Hemlibra and Actemra performed well. Overseas sales were ¥536.8 billion (+ ¥120.3 billion, +28.9%, YoY), driven by a substantial increase in exports of Hemlibra to Roche. Other revenue increased by 26.2% mainly due to increase in one-time income, etc., in addition to the increase in income related to Hemlibra...Overseas sales are expected to be ¥555.5 billion (+ ¥18.7 billion, +3.5%, YoY) due to growth in sales of Hemlibra...and NEMLUVIO, despite decrease in Actemra."

Commercial • Sales • Age-related Macular Degeneration • Atopic Dermatitis • Dermatitis • Diabetic Macular Edema • Hemophilia A • Idiopathic Arthritis • Inflammatory Arthritis • Macular Degeneration • Macular Edema • Novel Coronavirus Disease • Prurigo Nodularis • Pruritus • Retinal Vein Occlusion • Rheumatoid Arthritis • Scleroderma • Systemic Sclerosis • Vasculitis • Wet Age-related Macular Degeneration

Pre- and Postnatal Development Study of Nemolizumab, a Humanized Anti-Interleukin-31 Receptor A Monoclonal Antibody, in Cynomolgus Monkey. (PubMed, Birth Defects Res) - "Blocking IL-31 signaling with repeated dosing of nemolizumab did not adversely affect pregnancy, parturition, nursing, or postnatal physical and functional development in cynomolgus monkeys."

Journal • Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Prurigo Nodularis • CD123 • IL31RA