New England Journal of Medicine publishes positive final results from Phase 1/2a study of BIVV001 in people with severe hemophilia A

On September 10th, The New England Journal of Medicine published positive final results from the Phase 1/2a trial evaluating the safety, tolerability and pharmacokinetics of BIVV001 (rFVIIIFc-VWF-XTEN) in adult patients with severe hemophilia A. BIVV001 is an investigational factor VIII therapy designed to provide higher bleed protection in a once-weekly prophylactic treatment regimen. Sanofi and Sobi™ (STO:SOBI) collaborate on the development and commercialization of BIVV001.

  • BIVV001 is the first investigational factor VIII therapy independent of von Willebrand Factor and has the potential to transform replacement therapy for people with hemophilia A
  • It is uniquely designed to deliver near-normal factor activity levels for the majority of the week, extending bleed protection in a once-weekly dose
  • Results from the Phase 1/2a study showed that a single dose of BIVV001 achieved high sustained factor activity and a three- to four-fold increase in half-life when compared to conventional factor VIII replacement therapies

Click here to read the full press release from Sanofi.