Posted by Michael Wonder on 17 Apr 2018
FDA approves Vonvendi [von Willebrand factor (recombinant)] for peri-operative management of bleeding in adult patients with von Willebrand disease
17 April 2018 - Expanded use for Vonvendi – the first and only purified recombinant von Willebrand factor – builds on previously approved on-demand treatment indication.
Shire today announced the U.S. FDA has approved Vonvendi [von Willebrand factor (recombinant)], a recombinant von Willebrand factor (rVWF) treatment for peri-operative management of bleeding in adults (age 18 and older) with von Willebrand disease (VWD). Vonvendi is also indicated for on-demand treatment and control of bleeding episodes, and it is the first and only recombinant treatment for adults living with VWD, the most common inherited bleeding disorder.
The approval of Vonvendi in surgical settings was based on results from a Phase 3 prospective, open-label, multicenter trial to evaluate the efficacy and safety of Vonvendi with or without recombinant FVIII treatment in elective surgical procedures in adults (age 18 years and older) diagnosed with severe VWD. Results from the study showed Vonvendi met its primary endpoint, demonstrating overall haemostatic efficacy assessed 24 hours after the last peri-operative Vonvendi infusion or at completion of study visit, whichever occurred earlier.
