Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 56

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 56
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 EC approved Dupixent for use as an add-on therapy with intranasal corticosteroids in adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. In March 2020, the Japanese Pharmaceuticals and Medical Devices Agency approved Dupixent as add-on maintenance treatment for adults with inadequately controlled CRSwNP. I n September 2024, the FDA approved Dupixent (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled CRSwNP), expanding the initial FDA approval in CRSwNP from June 2019 for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. Eosinophilic esophagitis (EoE) EoE is a chronic and progressive inflammatory disease that damages the esophagus and prevents it from working properly; swallowing even small amounts of food can be a painful and worrisome choking experience. In severe cases, a feeding tube may be the only option to ensure proper calorific intake and adequate nutrition. As the disease progresses, patients may continue to experience symptoms despite multiple treatments.

| SANOFIFORM 20-F2024 | 23 |

| PART I                             |
| ITEM 4. Information on the Company |

On September 14, 2020, the FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE, and subsequently accepted the file for Priority Review on April 4, 2022. On May 20, 2022, the FDA approved Dupixent to treat patients with EoE aged 12 years and older. With this approval, Dupixent became the first and only medicine specifically indicated to treat EoE in the US. On December 16, 2022, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the approval of dupilumab in the EU to treat adults and adolescents with EoE. On January 30, 2023, the EC expanded the marketing authorization for Dupixent in the EU to include the treatment of EoE in adults and adolescents aged 12 years and older. On July 14, 2022, a Dupixent Phase 3