The U.S. Food and Drug Administration (FDA) has extended the scope of Shire’s VONVENDI to include perioperative management of bleeding in adults with von Willebrand disease (VWD). The therapy was first approved in the US in December 2015 for on-demand treatment and control of bleeding episodes. It is the first and only recombinant treatment for adults living with VWD, the most common inherited bleeding disorder.
People with VWD either lack sufficient quantities of von Willebrand factor (VWF) or functional VWF, and they may or may not have a secondary factor VIII (FVIII) deficiency. They all face an increased risk of bleeding during surgery. The expanded approval of VONVENDI allows healthcare professionals to apply the factor individually before, during or after surgery, with or without secondary factor VIII, depending on the patient’s specific needs.
VONVENDI relates to a substance patented by the Max Delbrück Center for Molecular Medicine Berlin-Buch (MDC) that arose from the work of Prof. Michael Bader and Dr Diego Walter. The scientists investigated serotonin-modulating agents that could be used for the treatment of bleeding disorders, including VWF. Ascenion, the MDC’s technology transfer partner negotiated the licence agreement with industry.