FDA expands approval of Vonvendi to include perioperative management of bleeding in adults with von Willebrand disease.- Shire.

The FDA has expanded approval of Vonvendi (recombinant von Willebrand Factor or rVWF), from Shire, 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.

Comment:Patients with VWD have a deficiency or dysfunction of VWF, a blood protein required for proper clotting. Because of this, the blood does not clot properly, which may result in heavy menstrual periods, easy bruising, or frequent nose bleeds. Veyvondi is an innovative VWF replacement therapy produced and formulated without the addition of any exogenous raw materials of human or animal origin, resulting in a product that contains only trace amounts of FVIII. This provides physicians with the flexibility to manage VWF levels.