Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 68

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 68
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 review, the medicine was approved in February 2022, in the US as the first treatment in adult patients with CAD. Enjaymo was approved by the Japanese Ministry of Health, Labor and Welfare in June 2022 and granted marketing authorization by the EC in November 2022. Swissmedic, the Korean MFDS and the Israeli Ministry of Health granted marketing approval for Enjaymo in June 2023, July 2023 and October 2023, respectively. Enjaymo is currently available in the US, Japan, Germany, Austria and the Netherlands. Additional commercial launches are ongoing. On November 29, 2024, Sanofi sold Enjaymo (sutimlimab) to Recordati, which acquired the global rights to the product and will be responsible for all activities after acquiring marketing authorization holder (MAH) status across all markets. Neurology Aubagio Aubagio (teriflunomide) is used to help manage multiple sclerosis (MS). This small molecule agent, taken once daily, works by reducing inflammation and modulating the immune system to prevent the immune attacks that cause MS symptoms . Aubagio is approved in more than 80 countries around the world including the US (since September 2012) for the treatment of patients with relapsing forms of MS; the EU (since August 2013) for the treatment of adult patients with relapsing remitting MS; and China (since July 2018). In June 2021, the EC approved Aubagio for the treatment of pediatric patients aged 10 to 17 years with relapsing-remitting multiple sclerosis (RRMS). In 2017, Sanofi reached settlement with all 20 generic Aubagio ANDA first filers, granting each a royalty-free license to enter the US market on March 12, 2023. In the EU, the first generic competitors to Aubagio became available in September 2023. Oncology Sarclisa Sarclisa (isatuximab) is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumor activity via multiple mechanisms of action. It was first approved in the US in March 2020 in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, and