Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) has entered into an expanded agreement with Sanofi to exercise early opt-in for the development and commercialisation of BIVV001, an investigational extended half-life factor VIII therapy with the potential to provide extended protection from bleeds with once-weekly dosing for people with haemophilia A. .
BIVV001 (rFVIIIFc-VWF-XTEN) is a novel and investigational recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for people with hemophilia A. BIVV001 builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to potentially extend its time in circulation. It is the only therapy that has been shown to break through the von Willebrand factor ceiling, which is believed to impose a half-life limitation on current factor VIII therapies. BIVV001 was granted orphan drug designation by the US Food and Drug Administration in August 2017 and the European Commission in June 2019.
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