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

Atopic Dermatitis-Related Problems in Daily Life, Goals of Therapy and Deciding Factors for Systemic Therapy: A Review. (PubMed, Pharmaceuticals (Basel)) - "Current guidelines and systematic reviews support the safety and efficacy of systemic therapy including conventional drugs (cyclosporine, methotrexate, and azathioprine), biologics (dupilumab and tralokinumab), and JAK inhibitors (baricitinib, upadacitinib, and abrocitinib) recommended for treating moderate and severe AD. Recently, additional biologics have been evaluated in clinical trials, including lebrikizumab, nemolizumab, eblasakimab, and OX40/OX40L, among others...Available data also indicate the importance of a personalized, stepwise, and multidisciplinary approach. This type of approach promotes patient compliance, satisfaction with therapy, and increased engagement, which all lead to better patient outcomes."

Journal • Review • Atopic Dermatitis • CNS Disorders • Depression • Dermatitis • Dermatology • Immunology • Mood Disorders • Psychiatry • Suicidal Ideation • TNFSF4

Galderma Receives U.S. FDA Approval for Nemluvio (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis (Businesswire) - "Galderma...announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nemluvio (nemolizumab) for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies....This approval is based on positive results from the phase III ARCADIA clinical trial program which evaluated the efficacy and safety of Nemluvio in combination with background TCS, with or without TCI, versus placebo in combination with TCS, with or without TCI, in 1,728 patients aged 12 years or older with moderate-to-severe atopic dermatitis....Further submissions to other regulatory authorities will continue in 2025."

FDA approval • Filing • Atopic Dermatitis

CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union (Businesswire) - "Galderma today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the European Union (EU). The CHMP has recommended nemolizumab’s approval 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 positive CHMP opinion is based on robust results from the phase III ARCADIA and OLYMPIA clinical trial programs in atopic dermatitis and prurigo nodularis, respectively."

CHMP • Atopic Dermatitis • Prurigo Nodularis

Long-term observation to determine durable efficacy and safety of novel paediatric atopic dermatitis treatment, nemolizumab. (PubMed, Br J Dermatol) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics

An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis (clinicaltrials.gov) - P2 | N=6 | Completed | Sponsor: Maruho Co., Ltd. | Active, not recruiting ➔ Completed | Trial primary completion date: Jul 2023 ➔ Jun 2024

Trial completion • Trial primary completion date • Immunology • Scleroderma • Systemic Sclerosis

Galderma’s Phase III OLYMPIA 1 Data Published in JAMA Dermatology Demonstrate That Nemolizumab Improves Core Signs and Symptoms of Prurigo Nodularis (Businesswire) - P3 | N=286 | OLYMPIA 1 (NCT04501666) | Sponsor: Galderma R&D | "The trial met both primary and all key secondary endpoints...After 16 weeks of treatment, more than three times as many nemolizumab-treated patients: i) Achieved an at least four-point improvement in itch intensity, as measured by the peak-pruritus numerical rating scale (PP-NRS), when compared to the placebo group (58.4% vs 16.7%; P<0.001). ii) Reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment (score of 0 or 1 and a ≥2-point improvement from baseline), compared to the placebo group (26.3% vs 7.3%; P<0.01). The trial also met all key secondary endpoints confirming rapid responses on itch and sleep disturbance as early as Week 4..."

P3 data • Immunology • Prurigo Nodularis

Long-term (68 weeks) administration of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: efficacy and safety data from a phase III study. (PubMed, Br J Dermatol) - "These data confirm the safety of long-term nemolizumab for paediatric patients with AD, and demonstrate improvements in pruritus, skin symptoms, and both patient and caregiver QoL over 68 weeks of treatment. (Funded by Maruho; Japan Registry of Clinical Trials identifier: jRCT2080225289)."

Journal • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Fatigue • Immunology • Pediatrics • Pruritus

Nemolizumab was associated with rapid and significant improvements in itch and sleep in patients with moderate-to-severe atopic dermatitis: Results from two global phase 3 pivotal studies (ARCADIA 1 and ARCADIA 2) (ISAD 2024) - "Significantly greater pro-portions of nemolizumab- vs placebo-treated patients achieved ≥4-point improvement in Sleep Disturbance NRS by Day 2 in ARCADIA 1 (8.7% vs 4.0%; p<0.01) and Day 1 in ARCADIA 2 (10.0% vs 2.6%; p<0.001). Treatment with nemolizumab + TCS/TCI led to rapid (within 2 days), statistically significant, and clinically meaningful improvements in itch and sleep in patients with MtS AD."

Clinical • P3 data • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • Sleep Disorder

Nemolizumab: “The committee discussed the issues identified in this application The Committee adopted the CHMP recommendation and scientific discussion together with the list of questions” (European Medicines Agency) - CHMP Final Minutes of the meeting on 27- 30 May 2024

CHMP • Immunology • Prurigo Nodularis

Maintained efficacy and safety of nemolizumab at week 48: results from two pivotal phase 3 studies (ARCADIA-1 and ARCADIA-2) in patients with moderate to severe atopic dermatitis (JDP 2024) - No abstract available

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Improvements in itch and sleep disturbance are maintained up to Week 48 with nemolizumab plus TCS/TCI treatment in patients with moderate-to-severe atopic dermatitis: Results from two global phase 3 pivotal studies (ARCADIA 1 and ARCADIA 2) (ISAD 2024) - "Patients achieving clinical response at W16 had also maintained improvements in itch, sleep disturbance & QoL with nemolizumab+TCS and/or TCI treatment at W48. The Q8W regimen was similar to the Q4W one in maintaining itch & sleep response rates."

Clinical • P3 data • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Pruritus • Sleep Disorder

ARCADIA trials: Can nemolizumab be a valid alternative to the therapies currently available? (PubMed, Med) - "ARCADIA 1 and ARCADIA 2 were two randomized, placebo-controlled phase 3 trials showing the effectiveness of nemolizumab with concomitant use of low-to-medium potency topical corticosteroids, and/or with or without topical calcineurin inhibitors, in adults and adolescents with moderate-to-severe atopic dermatitis. Coprimary endpoints were met in the nemolizumab plus background therapy groups in both trials, with significant differences versus placebo."

Clinical • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Effectiveness and Safety of Nemolizumab in Treating Atopic Dermatitis Among Japanese Patients: A Retrospective Study at a Single Center (ISAD 2024) - "Each patient received monthly subcutaneous injections of 60 mg nemolizumab, in conjunction with either topical steroid tacrolimus or delgocitinib. No other side effects were observed. While nemolizumab generally treats AD effectively with few adverse events, some cases show exacerbated symptoms or insufficient efficacy."

Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • CD123 • IL31RA

Efficacy and Safety of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis: The OLYMPIA 1 Randomized Clinical Phase 3 Trial. (PubMed, JAMA Dermatol) - P3 | "In this randomized clinical trial, nemolizumab monotherapy led to clinically meaningful and statistically significant improvements in core signs and symptoms of PN. ClinicalTrials.gov Identifier: NCT04501666."

Clinical • Journal • P3 data • Dermatology • Immunology • Prurigo Nodularis • Pruritus

Long-term efficacy and safety of nemolizumab up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: interim analysis (JDP 2024) - No abstract available

Clinical • Immunology • Prurigo Nodularis

A case of bullous pemphigoid after nemolizumab administration. (PubMed, J Dermatol) - No abstract available

Journal • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology

Nemluvio: "Nemolizumab exhibited significant pruritus improvement as early as day 2 or 1 in OLYMPIA programs and continuous improvement in pruritus and IGA0/1 up to 52 weeks in OLYMPIA LTE study"; Prurigo nodularis (Chugai) - Q3 FY2024 Results

P3 data • Immunology • Prurigo Nodularis

Current and Emerging Biologics for Atopic Dermatitis. (PubMed, Immunol Allergy Clin North Am) - "Type 2 immune polarization is central, though other cytokine pathways including Th22 and Th17/IL-23 have been described, suggesting additional therapeutic targets in a subset of patients. Dupilumab and tralokinumab are monoclonal antibodies currently approved for moderate-to-severe AD with lebrikizumab and nemolizumab in late stages of development."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL23A

Tape-strips transcriptomic analysis from patients with moderate to severe atopic dermatitis treated with nemolizumab (EADV 2024) - P3 | "Nemolizumab treatment induced significant downregulation of pruritus and hyperplasia markers, as well as Th17/Th22 and some Th1-related markers, which also correlated with improvements in clinical outcomes. Attenuation of Th2 and greater immune modulation was seen in severely itching patients, indicating that nemolizumab may hold even greater promise in patients heavily impacted by pruritus. 25 SEPTEMBER - 28 SEPTEMBER 2024 POWERED BY M-ANAGE.COM"

Clinical • Late-breaking abstract • Omic analysis • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Fibrosis • Immune Modulation • Immunology • Pruritus • Sleep Disorder • CCL2 • CCL3 • COL12A1 • COL1A1 • CXCL1 • CXCL8 • IGFBP3 • IL17A • IL17RA • IL22 • IL4R • KLK6 • KRT10 • MX1 • OASL • OSMR • S100A12 • S100A8 • S100A9 • SOX9 • TLR3

Nemolizumab long-term safety and efficacy up to 56 weeks in ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis (EADV 2024) - P3 | "Nemolizumab was well-tolerated up to W56 of treatment. Clinically meaningful improvements in AD signs and symptoms and patient-reported outcomes were observed with continuous treatment with nemolizumab. 25 SEPTEMBER - 28 SEPTEMBER 2024 POWERED BY M-ANAGE.COM"

Clinical • Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Durability of response to nemolizumab in patients with moderate-to-severe prurigo nodularis: Results from a randomised placebo-controlled withdrawal Phase 3b study (EADV 2024) - P3 | "Clinical responders to nemolizumab at week 52 had significantly lower relapse rates when continuing on nemolizumab than those withdrawn. These findings support the continued use of nemolizumab beyond 52 weeks of treatment among patients who are clinical responders. 25 SEPTEMBER - 28 SEPTEMBER 2024 POWERED BY M-ANAGE.COM"

Clinical • Late-breaking abstract • P3 data • Immunology • Prurigo Nodularis • Pruritus • IL31RA

Nemolizumab elicits an early and rapid itch response in prurigo nodularis within 2 days: A post hoc analysis of OLYMPIA 1&2 data (EADV 2024) - P3 | "In this post hoc analysis from the OLYMPIA 1&2 studies, a rapid onset of nemolizumab action on itch response was observed after the initial loading dose. The first significant separation between nemolizumab and placebo was observed within 1 day after the initial dose, with over a quarter of patients achieving a significant and clinically meaningful response within 1 week."

Retrospective data • Immunology • Prurigo Nodularis • Pruritus • IL31RA

Laboratory safety of nemolizumab in prurigo nodularis: Results from two phase 3 trials and one open-label extension study (EADV 2024) - P3 | "There were no clinically significant changes in haematology and clinical chemistry parameters attributed to nemolizumab in patients with PN. These findings support the use of nemolizumab in PN without laboratory monitoring."

Clinical • P3 data • Eosinophilia • Hematological Disorders • Immunology • Prurigo Nodularis • IL31RA

Exposure Response To Support Dose Selection Of Nemolizumab In Patients With Prurigo Nodularis (EADV 2024) - "Exposure-efficacy and exposure-safety analyses provided supportive evidence of the selected Q4W doses in patients with PN, i.e. 30 mg (60 mg LD) with a 60 mg dose adjustment based on BW cutoff of 90 kg. The proposed tiered dose adjustment based on BW is adequate to achieve therapeutic exposure and clinical benefit without exposing patients to increased risks."

Clinical • Asthma • Atopic Dermatitis • Dermatitis • Immunology • Pain • Prurigo Nodularis • Pruritus • Respiratory Diseases

Absence of Clinically Impactful Immunogenicity of Nemolizumab in Long-Term Treatment of Patients with Atopic Dermatitis and Prurigo Nodularis (EADV 2024) - "There was no discernable impact of immunogenicity (ADA and Nab) on the overall clinical benefit and risk of nemolizumab for AD and PN indications according to the integrated immunogenicity data analysis performed on a robust dataset of 1458 patients from both indications."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Prurigo Nodularis • IL31RA