EMA validates MAA application from Shire for Veyvondi to prevent bleeding in patients with von Willebrand Disease.

Shire plc the leading biotechnology company focused on serving individuals with rare diseases, announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for Veyvondi to prevent and treat bleeding episodes and peri-operative bleeding in adults (age 18 and older) diagnosed with von Willebrand Disease (VWD), the most common inherited bleeding disorder.

Currently available in the U.S. as Vonvendi [von Willebrand factor (Recombinant)], Veyvondi is the first and only recombinant von Willebrand factor (rVWF) treatment for adults living with VWD.

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.