Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 65

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 65
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 clinical studies of adults and children with ASMD. Xenpozyme is given as an intravenous infusion once every two weeks, and the dose is based on body weight. Xenpozyme has to date been commercialized in 25 countries, however only 15 of those have full reimbursement by payers. By 2030, it is anticipated that Xenpozyme will have been launched in many additional markets worldwide. ALTUVIIIO ALTUVIIIO (Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein) is a first-in-class high-sustained factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with hemophilia A. Hemophilia A is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation factor VIII, resulting in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia A bleed for a longer time than normal. ALTUVIIIO temporarily replaces the missing coagulation factor VIII by intravenous injection. In adults and adolescents, it is the first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation. ALTUVIIIO was first approved in February 2023 by the FDA, which had previously granted Breakthrough Therapy designation in May 2022 (the first factor VIII therapy to receive this designation); fast-track designation in February 2021; and Orphan Drug designation in 2017. ALTUVIIIO has since been approved the by regulatory authorities in Japan, Taiwan, Macau and Hong Kong, and has been commercialized in Japan and Taiwan.The European Commission (EC) granted Orphan Drug designation in June 2019, and a marketing authorization application was filed with the European Medicines Agency (EMA) in May 2023. ALTUVOCT (the brand name of ALTUVIIIO in Europe) received EC marketing authorization in June 2024. ALTUVIIIO is developed and commercialized in collaboration with Swedish Orphan Biovitrum AB (Sobi), whose territories include Europe, Russia, the Middle East, and some countries in North Africa. Eloctate Eloctate (antihemophilic factor (re