Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 93

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 93
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 products s ee also “ — B.2. Main Biopharma medicines and vaccines ”. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, jointly developed with Regeneron. Dupixent has received regulatory approvals in several countries for multiple indications. Details about clinical and regulatory activities for Dupixent during 2024 for the treatment of respiratory, dermatology and gastrointestinal diseases are provided below: a. The FDA approved Dupixent as an add-on maintenance treatment of adults with COPD and an eosinophilic phenotype. Dupixent is the first biologic medicine approved in the US to treat these patients. The National Medical Products Administration in China approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Dupixent has now been approved for the treatment of COPD in more than 30 countries worldwide, including the 27 countries in the EU. In Japan, approval is expected in the first half of 2025. b. CSU is a chronic skin condition that causes sudden and debilitating hives and persistent itch, which can impact quality of life. LIBERTY-CUPID Study C, a confirmatory Phase 3 study, met the primary and key secondary endpoints for the treatment of patients with uncontrolled, biologic-naive CSU receiving background therapy with antihistamines. The new Study C data supported regulatory resubmission of the supplemental biologics license application (sBLA) for Dupixent in the US in October 2024, with a target action date for the FDA decision of April 18, 2025. This positive study confirmed results from Study A, the first Phase 3 study of Dupixent in this setting. In early in 2024, Japan was the first country to approve Dupixent for adult and adolescent CSU patients based on the results from Study A. The indication is also under review in the EU based on results from Study A and Study B (patients uncontrolled on standard-of-care H1 ant