Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 59

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 59
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, which can significantly affect daily activities and contribute to sleep disturbances, anxiety, and depression. COPD also imposes a major health and economic burden due to frequent acute exacerbations, often requiring treatment with systemic corticosteroids and/ or antibiotics. While smoking and exposure to harmful particles are primary risk factors, the disease may still progress in those who have quit smoking. Around 50% of COPD patients continue to experience exacerbations despite receiving triple inhaled therapy. In the US, approximately 300,000 individuals have inadequately controlled COPD with an eosinophilic phenotype, a subgroup prone to a 30% increase in exacerbations and a higher risk of COPD-related hospital readmissions within a year.

| 24 | SANOFIFORM 20-F2024 |

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

On July 3, 2024, following a positive review by the EMA, the EC approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by elevated blood eosinophils. This 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 those on a LABA/LAMA combination if ICS is unsuitable. The EC was the first regulatory agency worldwide to grant approval for Dupixent in COPD patients. On September 10, 2024, a pooled analysis from the BOREAS and NOTUS Phase 3 studies showed that Dupixent reduced exacerbations and improved lung function compared to placebo in adults with uncontrolled COPD and evidence of type 2 inflammation (i.e. raised blood eosinophils). The results were presented for the first time, in collaboration with Regeneron, at the 2024 European Respiratory Society (ERS) International Congress. On September 27, 2024, the National Medical Products Administration (NMPA) in China also approved Dupixent as an add-on treatment for adults with uncontrolled COPD and raised blood eosinophils. This approval similarly covers patients on combinations of ICS, LABA, and LAMA, or LABA and LAMA if ICS is not appropriate. Dupixent has now been approved for the treatment of COPD in over 30 countries, including the 27 EU member states. On September 27, 2024, the FDA approved Dup