FDA Approval of Vonvendi18 Apr 2018 09:38
Shire plc : FDA APPROVES VONVENDI� FOR PERIOPERATIVE MANAGEMENT OF BLEEDING IN ADULT PATIENTS WITH VON WILLEBRAND DISEASE
FDA APPROVES VONVENDI� [VON WILLEBRAND FACTOR (RECOMBINANT)] FOR PERIOPERATIVE MANAGEMENT OF BLEEDING IN ADULT PATIENTS WITH VON WILLEBRAND DISEASE1
Expanded use for VONVENDI - the first and only purified recombinant von Willebrand factor - builds on previously approved on-demand treatment indication1
VONVENDI now offers an individualized approach to bleed control in appropriate patients undergoing surgery1
von Willebrand disease is the most common inherited bleeding disorder, affecting up to one percent of the U.S. population2
Cambridge, Ma. - April 17, 2018 - Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare disease, today announced the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (recombinant)], a recombinant von Willebrand factor (rVWF) treatment for perioperative management of bleeding in adults (age 18 and older) with von Willebrand disease (VWD).1 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.1,3-4
"The expanded approval of VONVENDI represents a new treatment option for the surgical setting that can be tailored to each patient's individual needs,"1,3-5 said Andreas Busch, Global Head of Research and Development, Shire. "It's an important milestone in support of our vision of personalizing treatment and helping to address unmet needs for people with bleeding disorders."1,3-5
People with VWD lack proper quantities of VWF or functioning VWF, and they may or may not have a secondary factor VIII (FVIII) deficiency.5 Since not every person with VWD or every bleed requires FVIII replacement, VONVENDI allows healthcare providers to dose recombinant VWF independent of recombinant FVIII based on clinical judgement for each patient, taking into account severity, site of bleeding, the patient's medical history and monitoring of appropriate clinical and laboratory measures.1 Independent dosing with VONVENDI offers an individualized approach to bleed control in appropriate patients undergoing surgery.1
"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, M.D., 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.1,7 The expanded use for VONVENDI in surgical settings gives healthcar