Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 55

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 55
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 of type 2 inflammation, called fractional exhaled nitric oxide (FeNO), that plays a major role in asthma. In October 2021, the FDA approved Dupixent as an add-on maintenance treatment for patients aged six to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma, thereby bringing a new treatment for children who may be suffering from life-threatening asthma attacks and poor lung function affecting their ability to breathe, which could potentially continue into adulthood. On April 7, 2022, the EC approved Dupixent for use in children aged six 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, whose symptoms are inadequately reduced with medium to high dose inhaled corticosteroids (ICS) plus another medicine for maintenance treatment. In March 2019, Dupixent was approved in Japan for treating patients aged 12 years and over with severe or refractory asthma whose symptoms are inadequately controlled with existing therapies. In November 2023, Dupixent received approval in China for treatment of moderate to severe asthma patients aged 12 years and over with type 2 inflammation . I n February 2024 , topline results from the VESTIGE Phase 4 clinical study were presented at the 2024 American Academy of Allergy, Asthma, and Immunology Annual Meeting. This study evaluated the effects of Dupixent on airway remodeling in adults with uncontrolled moderate-to-severe asthma characterized by an eosinophilic phenotype or those dependent on oral corticosteroids. In 2024, Sanofi initiated a Phase 3 study for children aged 2 to 6 years suffering from asthma. This parallel, two-arm Phase 3 study aims to evaluate the efficacy and long-term safety of dupilumab treatment in children with uncontrolled asthma and/or recurrent severe asthmatic wheeze. Chronic rhinosinusitis with nasal polyposis (CRSwNP) CRSwNP is a chronic disease of the upper airway that obstructs the sinuses and nasal passages. It can lead to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, and facial pressure. In June 2019, the FDA approved Dupixent for use with other medicines to treat CRSwNP in adults whose disease is not controlled. In October 2019, the