Shire: FDA APPROVES VONVENDI

Shire (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.

As quoted in the press release:

“The expanded approval of VONVENDI represents a new treatment option for the surgical setting that can be tailored to each patient’s individual needs,”^1,3-5said 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.

Click here to read the full press release.