Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 54

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 54
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 the Company |

Dupixent inhibits IL4/IL-13 pathways, both key and central drivers of type 2 inflammation, thereby significantly improving itching and skin lesions and other important measures that impact a patient’s quality of life. The inclusion of the results from the five-year OLE study for adults in the Dupixent label was approved in Europe in June 2023, and in the US by the FDA in October 2023. In March 2023, positive results from the clinical study assessing Dupixent in adults and adolescents with uncontrolled moderate- to-severe atopic hand and foot dermatitis were presented in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting. The study, evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints. In August 2023, the clinical section of the Dupixent label in Europe was updated to include the hand and foot dermatitis population. In January 2024, the Dupixent US label was updated with data further supporting use in AD with moderate-to-severe hand and foot involvement. These Phase 3 data are from the first and only study evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions under way in additional countries. Asthma Dupixent was granted marketing authorization by the FDA in October 2018 as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. In May 2019, the EC approved Dupixent for use as an add-on maintenance treatment in severe asthma patients aged 12 years and older with type 2 inflammation whose symptoms are inadequately reduced by other treatments. In September 2020, new long-term data from a Phase 3 open-label extension study showed sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma. On May 17, 2021, detailed results from a Phase 3 study showed Dupixent significantly reduced severe asthma attacks, and within two weeks rapidly improved lung function in children aged six to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2 inflammation. Moreover, Dupixent significantly improved overall asthma symptom control and reduced an airway biomarker