Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 95

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 95
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IA. Approval in Europe for the treatment of patients with pJIA was obtained in January 2025 . Tzield , a CD3-directed monoclonal antibody, is the first and only disease modifying therapy in type 1 diabetes (T1D), a chronic autoimmune condition where the body’s ability to regulate blood sugar levels is impacted due to the gradual destruction of insulin producing beta cells by one’s own immune system. The product is approved by the FDA to delay the onset of Stage 3 T1D in adults and children eight years and older diagnosed with Stage 2 T1D. In addition, the potential of Tzield to slow the progression of Stage 3 T1D in newly diagnosed children and adolescents is currently being evaluated in a Phase 3 clinical program. In 2024, the EMA accepted for review the regulatory submission for Tzield in children and adolescents to delay the onset of stage 3 T1D, as well as for early intervention in stage 3 T1D.

| SANOFIFORM 20-F2024 | 39 |

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

Rezurock is a selective ROCK2 (rho-associated coiled-coil–containing protein kinase-2) inhibitor that was first approved by the FDA for the treatment of adult and pediatric patients aged 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. Rezurock is now approved in multiple countries, including China, the UK and Canada. In 2024, the EMA accepted for review the regulatory submission of Rezurock for the third line treatment of chronic GVHD. The EMA granted an orphan designation in 2019 for this indication. A Phase 3 study is evaluating Rezurock on top of azithromycin and standard-of-care regimen of immunosuppression in adult participants who have evidence of progressive chronic lung allograft dysfunction despite azithromycin therapy. Nexviazyme is a long-term enzyme replacement therapy targeting the mannose-6-phosphate receptor to effectively clear glycogen build-up in muscle cells. This enzyme replacement therapy is approved for the treatment of patients with Pompe disease, a rare disease caused by a deficiency of the enzyme acid alpha-glucosidase (GAA) . In Europe, the treatment is marketed under the brand name Nexviadyme. In 2024, new data from the Mini