Press Release: EAACI: Dupixent demonstrated superiority over Xolair (omalizumab) in chronic rhinosinusitis with nasal polyps in patients with coexisting asthma in first-ever presented phase 4 head-to-

Sanofi and Regeneron announced positive Phase 4 EVEREST study results, revealing Dupixent's superiority over Xolair in treating adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. Dupixent outperformed Xolair across all primary and secondary efficacy endpoints for both CRSwNP and asthma, showing significant improvements in nasal polyp size, sense of smell, lung function, and disease control as early as four weeks. These findings reinforce Dupixent's efficacy by targeting IL-4 and IL-13, key drivers of type 2 inflammation in respiratory diseases.

Analysis

Sanofi (SNY) and Regeneron (REGN) reported positive results from the EVEREST Phase 4 study, where Dupixent demonstrated significant superiority over Novartis's (NVS) Xolair in treating adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. In this first-ever head-to-head trial of biologic medicines for this specific patient group, Dupixent outperformed Xolair on all primary and secondary CRSwNP efficacy endpoints, including a 1.60-point greater reduction in nasal polyp size (p<0.0001) and an 8.0-point superior improvement in sense of smell (p<0.0001) at 24 weeks. Dupixent also surpassed Xolair in all asthma-related endpoints, notably achieving a 150 mL greater improvement in lung function (FEV1, p=0.0032). These improvements were often observed as early as four weeks. The study, involving 360 adults, indicated generally similar safety profiles, with overall adverse event rates of 64% for Dupixent and 67% for Xolair. These findings underscore Dupixent's efficacy, attributed to its targeting of IL-4 and IL-13, and are poised to strengthen its market leadership and influence clinical practice in respiratory diseases driven by type 2 inflammation, potentially impacting Xolair's competitive standing in this segment.

Key Decisions for Investors

• Investors in Sanofi (SNY) and Regeneron (REGN) should view these positive head-to-head results for Dupixent as a significant catalyst, likely bolstering its competitive positioning and revenue potential in the treatment of CRSwNP with coexisting asthma.
• Holders of Novartis (NVS) should assess the potential for market share erosion for Xolair in patients with CRSwNP and coexisting asthma, given Dupixent's demonstrated superiority across multiple key efficacy endpoints in this direct comparison.
• The study reinforces the clinical value of Dupixent's IL-4/IL-13 pathway inhibition, suggesting continued strong performance for the drug; therefore, monitoring its expanded adoption and impact on treatment paradigms for type 2 inflammatory diseases is warranted.