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VONVENDI® Receives Expanded FDA Approval for Surgery in VWD Patients

April 25, 2018
VONVENDI® Receives Expanded FDA Approval for Surgery in VWD Patients

Shire recently announced that the U.S. Food and Drug Administration (FDA) has approved the company’s recombinant von Willebrand factor (rVWF) product VONVENDI® for perioperative management of bleeding in adults (age 18 and older) with von Willebrand disease (VWD). The therapy had already been approved for the on-demand treatment and control of bleeding episodes in adults 18 and older who have VWD.

The new approval was based on results from a Phase 3 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. According to a recent press release, study results showed that VONVENDI demonstrated overall hemostatic efficacy at 24 hours after the last perioperative infusion of the therapy or at completion of study visit, whichever occurred earlier. The overall median once-daily dosing frequency after surgery was demonstrated to “normalize hemostasis in appropriate patients.” One study participant developed deep vein thrombosis three days after undergoing hip replacement surgery while receiving VONVENDI.

“Persons with von Willebrand disease face a heightened risk of bleeding during surgery and may require factor treatment before, during or after surgery,” said Michael Tarantino, MD, Professor of Pediatrics and Medicine, University of Illinois College of Medicine, and Medical Director and President, The Bleeding and Clotting Disorders Institute. “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. 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.”

Source: Globalnewswire, April 17, 2018