Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 58

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 58
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 hands and feet, but can also affect the throat and upper airways. On July 29, 2021 a pivotal Phase 3 study evaluating Dupixent in patients with moderate-to-severe CSU met its primary endpoints and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itching and hives for biologic-naive pa tients, compared to those treated with antihistamines alone (placebo) in Study A (the first of three studies) of the LIBERTY CUPID clinical program. Study B of the clinical study evaluated Dupixent in adults and adolescents who remain symptomatic despite standard-of-care treatment and are intolerant or incomplete responders to an anti-IgE therapeutic (omalizumab). Although positive numerical trends in reducing itching and hives were observed, the study was stopped due to futility based on a pre-specified interim analysis. Further analysis demonstrated that Dupixent met the EU primary endpoint (UAS7 at week 24). Th e safety data were generally consistent with the known safety profile of Dupixent in its approved indications. In December 2022, Dupixent was submitted to the FDA for the CSU indication. In October 2023, the FDA issued a Complete Response Letter (CRL) stating that additional efficacy data were required to support approval; it did not identify any issues with safety or manufacturing. Accordingly, a third clinical study (Study C) was initiated to provide additional efficacy data. In September 2024, the Dupixent confirmatory Phase 3 study (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologic-naive CSU receiving background therapy with antihistamines. This positive study confirmed results from Study A, the first Phase 3 study of Dupixent in this setting. Earlier in 2024, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on the results from Study A (February 2024), followed by approvals in the United Arab Emirates (UAE) (September 2024) and Brazil (November 2024). Chronic obstructive pulmonary disease (COPD) COPD is a progressive respiratory disorder that damages the lungs and reduces lung function, making it the fourth leading cause of death worldwide. Key symptoms include persistent coughing, excessive mucus production, and shortness of breath