Shire announced that the Food and Drug Administration (FDA) has expanded the indication of Vonvendi (von Willebrand factor [recombinant]) for the treatment of perioperative management of bleeding in adults with von Willebrand disease.
Vonvendi, a recombinant von Willebrand factor, was initially approved in December 2015 for on-demand treatment and control of bleeding episodes.
The expanded approval was supported by data from a Phase 3 prospective, open-label, multicenter trial that evaluated the safety and efficacy of Vonvendi with or without recombinant factor VIII (FVIII) treatment in elective surgical procedures in patients aged ≥18 years diagnosed with severe von Willebrand disease. In the trial, Vonvendi met the primary endpoint, showing overall hemostatic efficacy assessed 24 hours after the last perioperative infusion or at completion of study visit, whichever occurred earlier.
“For surgeries requiring repeated, frequent infusions with combined von Willebrand factor and factor VIII concentrates, an excessive rise in factor VIII levels may increase the risk of thromboembolic complications, such as blood clots,” said Michael Tarantino, MD, professor at the University of Illinois College of Medicine. “The expanded use for Vonvendi in surgical settings gives healthcare professionals flexibility in treating von Willebrand disease with an appropriate dose of von Willebrand factor, with or without recombinant factor VIII, based on each patient’s unique needs.”
The prescribing information was also updated to include new pharmacokinetic and storage data stating that Vonvendi can be stored at refrigerated or room temperatures.
For more information call (800 536-7878 or visit Vonvendi.com.