Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 73

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 73
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 diagnosed cGVHD patients and (ii) chronic lung allograft dysfunction (CLAD) post bilateral lung transplant. Currently, there are no approved targeted therapies for either newly diagnosed cGVHD or CLAD. Praluent Praluent (alirocumab) is a human monoclonal antibody (mAb) for self-administered injection every two weeks or once-monthly. It blocks the interaction of proprotein convertase subtilisin/kexin type 9 (PCSK9) with low-density lipoprotein (LDL) receptors, increasing the recycling of LDL receptors and reducing LDL cholesterol levels. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy in certain adult patients and in pediatric patients eight years of age and older with heterozygous familial hypercholesterolaemia (HeFH) with uncontrolled LDL cholesterol. Praluent has been approved in more than 60 countries worldwide, including the US (in 2015), Canada and Switzerland, as well as in the European Union (in 2015). In 2018, the FDA approved a Praluent label update for patients currently requiring LDL apheresis therapy. In March 2019 in the EU and in April 2019 in the US, Praluent was approved for use in patients with established cardiovascular disease to reduce the risk of cardiovascular events. In November 2023, following positive review by EMA, the EC approved a Praluent label update for pediatric HeFh patients aged eight years and older. In December 2019, Praluent was approved in China, where it started to be commercialized in May 2020. Since April 2020, Regeneron has been responsible for commercialization of Praluent in the US, and Sanofi has been responsible for all other markets outside the US. For additional information on the commercialization of this medicine, see “Item 5. Operating and Financial Review and Prospects — A.1.7. Financial Presentation of Alliances — Alliance Arrangements with Regeneron Pharmaceuticals Inc. (Regeneron).” Thymoglobulin Thymoglobulin (anti-thymocyte globulin) is a polyclonal anti-human thymocyte antibody preparation that acts as a broad immunosuppressive and immunomodulating agent. In the US, Thymoglobulin is indicated for the prophylaxis and/or treatment of acute rejection in patients receiving a kidney transplant, used in conjunction with con