US regulators have expended the scope of Shire’s Vonvendi to include perioperative management of bleeding in adults with von Willebrand disease (VWD).
The therapy was initially approved in the US in December 2015 for on-demand treatment and control of bleeding episodes, and is the first and only recombinant treatment for adults living with VWD, the most common inherited bleeding disorder.
People with VWD lack proper quantities of von Willebrand factor (VWF) or functioning VWF, and they may or may not have a secondary factor VIII (FVIII) deficiency.
“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, professor of Pediatrics and Medicine, University of Illinois College of Medicine, and medical director and president, The Bleeding and Clotting Disorders Institute.
“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.”
Vonvendi is currently under review in Europe for prevention and treatment of bleeding episodes and peri-operative bleeding in adults diagnosed with VWD.