Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 64

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 64
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 Prevalence estimates vary across regions. Classic FD mutations are estimated to be approximately 1:40,000 in males with more wide-ranging estimates for non-classic in both males and females . Fabrazyme has been marketed in the EU since 2001 and in the US since 2003 and is approved in more than 70 countries. Aldurazyme Aldurazyme (laronidase) is the only approved ERT for mucopolysaccharidosis type 1 (MPS I), an inherited lysosomal storage disorder caused by a deficiency of alpha-L-iduronidase, a lysosomal enzyme normally required for the breakdown of certain complex carbohydrates known as glycosaminoglycans (GAGs). MPS I is multi-systemic, and children with MPS I are described as having either a severe or attenuated form of the disorder based on age of onset, severity of symptoms, rate of disease

| 26 | SANOFIFORM 20-F2024 |

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

progression and whether there is early and direct involvement of the brain. MPS I occurs in approximately one per 100,000 live births worldwide, but incidence and patient severity vary among regions. Sanofi markets Aldurazyme in the EU and the US (since 2003) and in more than 75 other countries. Xenpozyme Xenpozyme (olipudase alfa) is an ERT designed to replace deficient or defective acid sphingomyelinase (ASMD), an enzyme that allows for the breakdown of the lipid sphingomyelin. In individuals with ASMD, an insufficiency of the ASM enzyme means sphingomyelin is poorly metabolized, potentially leading to lifelong accumulation in and damage to multiple organs. The significance of the unmet need that Xenpozyme addresses has been recognized by Japan’s PMDA with Sakigake designation, by the EU with PRIME designation, and by the FDA with Breakthrough designation. Xenpozyme was approved first in Japan on March 28, 2022, followed by Europe on June 24, 2022 and the US on August 31, 2022. Xenpozyme is the first and only ERT for the treatment of non-central nervous system manifestations of ASMD, with demonstrated improvements in hepatosplenomegaly, pulmonary, liver and hematologic function, dyslipidemia, and growth (children only) in