Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 97

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 97
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d) in RRMM patients who have received at least one prior line of therapy is under evaluation in a Phase 3 study (IRAKLIA); in this program, Sarclisa is administered subcutaneously using Enable Injections’ enFuse hands-free on-body device delivery system. The co-primary endpoints of this study were met, supporting regulatory submissions in the US and in the EU that are planned during the first half of 2025. Sarclisa is also assessed in a Phase 3 study in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smoldering MM, and in a Phase 2 study in new combinations with emerging novel mechanisms of action for the treatment of patients with RRMM or newly diagnosed MM patients. Fluzone HD is a high-dose quadrivalent influenza vaccine licensed in the US and in Europe for the elderly population, who do not respond as well to standard-dose influenza vaccines due to aging of the immune system (immuno-senescence). A Phase 3 study to evaluate immunogenicity and safety of Fluzone HD in participants 50 through 64 years of age was initiated in 2024. MenQuadfi : Sanofi’s Men ACYW-TT vaccine is our latest advance in meningococcal quadrivalent conjugate vaccination, designed to help protect an expanded patient group including infants and adolescents through older adults. MenQuadfi is already licensed in the US (for people aged two years and over), and in Europe and several other countries (for people aged 12 months and over). MenQuadfi has also received WHO pre-qualification for people aged 12 months and above. In 2024, positive safety and immunogenicity results from a Phase 3 study of MenQuadfi to protect infants from six weeks of age against invasive meningococcal disease caused by serogroups ACWY, supported regulatory submission in the US. The FDA accepted for review the supplemental biologics license application for the potential extension of the indication to include children aged six weeks to 23 months through active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. The target action date for the FDA decision is May 23, 2025. B.4.2. R&D Expenditures for late stage development Expenditures on research and development amounted to € 7