Media Update: New Dupixent® (dupilumab) data at ERS adds to body of safety and efficacy data in chronic respiratory diseases

Media Update

New Dupixent® (dupilumab) data at ERS adds to body of safety and efficacy data in chronic respiratory diseases

Paris, August 30, 2022. More than 10 scientific abstracts evaluating Dupixent® (dupilumab) in moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) will be presented at the European Respiratory Society (ERS) International Congress 2022 from September 4 to 6. The data add to a growing body of clinical and real-world evidence illustrating the benefit of Dupixent in targeting IL-4 and IL-13, key and central drivers of the type 2 inflammation that play a major role in asthma and CRSwNP.

Presentations include new analyses from a Phase 3 open-label extension trial (TRAVERSE), which showed that treatment with Dupixent reduced asthma exacerbations, improved lung function and reduced the need for oral corticosteroids in patients with moderate-to-severe asthma aged 12 years and older for up to three years. The safety results of this trial were generally consistent with the known safety profile of Dupixent in its respiratory indications.

Late-breaking, new long-term data from the longest global Phase 3 open-label extension trial of children aged 6-11 years with moderate-to-severe asthma (EXCURSION) will also be presented.

In addition, results of a Phase 3 trial in adults with CRSwNP will be presented, showing that the majority of patients treated with Dupixent maintained a clinically meaningful response over one year on multiple clinical endpoints, including nasal polyps score, loss of smell score and the Sino-nasal Outcome Test-22. The safety results were generally consistent with the known safety profile of Dupixent in its respiratory indications.

Data to be presented at ERS 2022

Clinical Efficacy and Safety of Dupixent in Children with Asthma

• Late-BreakingOral Presentation (September 5, 4:30-4:35 CEST):

• 1. #OA2955: Assessment of the long-term safety and efficacy of dupilumab in children
     with asthma: LIBERTY ASTHMA EXCURSION, Leonard Bacharier
• Oral Presentation (September 5, 4:05-4:10 CEST) and Poster:
• 1. #OA2950: Dupilumab efficacy in children with uncontrolled type 2 asthma with baseline high/medium ICS dose, Jorge Maspero
• Oral Presentation (September 5, 4:15-4:20 CEST) and Poster:
• 1. #OA2952: Continuous Associations of Type 2 Biomarkers and Efficacy of Dupilumab in Children With Uncontrolled, Moderate-to-Severe Asthma, Leonard Bacharier

Impact of Dupixent on Key Efficacy and Safety Measures in Adolescents and Adults with Asthma

• Oral Presentation (September 6, 9:55-10:00 CEST) and Poster:

• 1. #OA3672: Dupilumab improved lung function and reduces exacerbations in patients
     with 1, 2, or 3 prior exacerbations: TRAVERSE, Jonathan Corren
• Oral Presentation (September 6, 10:10-10:15 CEST) and Poster:
• 1. #OA3675: Relation between reduction in fractional exhaled nitric oxide and efficacy in asthma patients treated with dupilumab, Ian Pavord
• Poster #PA3191: Randomised, double-blind,placebo-controlled study to assess long-term effect of dupilumab on prevention of lung function decline (LFD) in patients with uncontrolled moderate-to-severe asthma: ATLAS trial, Ian Pavord

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• Poster #PA3209: Effect of Dupilumab on asthma control and asthma-related quality of life in
  patients with uncontrolled, moderate-to-severe type 2 asthma: TRAVERSE OLE study, Ian Pavord
• Poster #PA3212: Dupilumab reduces OCS use and improves lung function in patients with severe OCS-dependent asthma, Christian Domingo Ribas
• Poster #PA3210: Biomarkers associated with lung function decline and dupilumab response in patients with moderate-to-severe asthma, Ian Pavord

Real-World Effectiveness of Dupixent in People with Asthma

• Poster #PA2390: Real-World Effectiveness (RWE) of Dupilumab in Reducing Healthcare Resource Utilization among Moderate-to-Severe Asthma Patients, Ajinkya Pawar

Clinical Efficacy of Dupixent in People with CRSwNP

• Poster #PA3197: Onset, Maintenance, and Durability of Response with Dupilumab in Chronic Rhinosinusitis with Nasal Polyps, Claus Bachert

About Dupixent

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4(IL-4) and interleukin-13(IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, CRSwNP and eosinophilic esophagitis (EoE), as well as investigational diseases such as prurigo nodularis.

In the EU, Dupixent is approved in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO, who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. For adolescents and adults 12 years and older with severe asthma with type 2 inflammation, patients must be inadequately controlled with high dose ICS plus another medicinal product for maintenance treatment.

Dupixent has received regulatory approvals around the world for use in in certain patients with atopic dermatitis, asthma, CRSwNP or EoE in different age populations. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in more than 60 countries, including in the European Union and Japan. More than 450,000 patients have been treated with Dupixent globally.

Dupilumab Development Program

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including prurigo nodularis, pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

About Sanofi

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