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    Sanofi  614  0 Kommentare Dupixent (dupilumab) showed positive topline results in two Phase 3 trials of patients with chronic rhinosinusitis with nasal polyps

    Dupixent (dupilumab) showed positive topline results in two Phase 3 trials of patients with chronic rhinosinusitis with nasal polyps

    • Dupixent significantly reduced nasal polyp size, nasal congestion severity, and need for systemic corticosteroids and/or surgery
    • Dupixent has now demonstrated positive late-stage results in three Type 2 or allergic inflammatory diseases: atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps
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    Paris and Tarrytown, N.Y. - October 16, 2018 - Two pivotal Phase 3 placebo-controlled trials evaluating Dupixent (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps ("CRSwNP") met all primary and secondary endpoints.

    On the co-primary endpoints for both trials at 24 weeks, patients treated with Dupixent added to a standard-of-care corticosteroid nasal spray experienced a 51% and 57% improvement in their nasal congestion/obstruction severity compared to 15% and 19% improvement with nasal spray alone (placebo) (-1.25 and -1.34 for Dupixent compared to -0.38 and -0.45 for placebo, on a 0-3 scale ). Dupixent treated patients had  a 27% and 33% reduction in their nasal polyps score compared to a 4% and 7% increase for placebo (-1.71 and -1.89 for Dupixent compared to 0.10 and 0.17 for placebo, on a 0-8 scale that measures bilateral polyps size by endoscopy).

    Dupixent also met all secondary endpoints in both trials, including demonstrating a significant reduction in the need for systemic corticosteroids or surgery, and improvements in smell and chronic rhinosinusitis symptoms. In a pre-specified group of patients with comorbid asthma, Dupixent significantly improved lung function and asthma control (p < 0.0001 for all primary and secondary endpoints in both trials). Dupixent blocks the IL-4 and IL-13 signaling pathways.

    "Dupixent has now demonstrated significant late-stage efficacy in three Type 2 or allergic inflammatory diseases, indicating that IL-4 and IL-13 are required drivers of Type 2 or allergic inflammation in general. With these data, Dupixent has now been shown to address this inflammation across the complete airway, which manifests in the upper respiratory tract as polyps and congestion, and in the lower airway as asthma," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "We look forward to U.S. regulatory action on our moderate-to-severe asthma application later this month, and are continuing our development program in additional Type 2 or allergic inflammatory diseases with high unmet need including pediatric asthma, pediatric and adolescent atopic dermatitis, eosinophilic esophagitis, and food and environmental allergies."

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    Sanofi Dupixent (dupilumab) showed positive topline results in two Phase 3 trials of patients with chronic rhinosinusitis with nasal polyps Dupixent (dupilumab) showed positive topline results in two Phase 3 trials of patients with chronic rhinosinusitis with nasal polyps Dupixent significantly reduced nasal polyp size, nasal congestion severity, and need for systemic corticosteroids …

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