Baxalta’s VONVENDI Wins FDA Approval

Baxalta received approval from the FDA for VONVENDI [von Willebrand factor (Recombinant)], the first recombinant treatment for adults with von Willebrand Disease (VWD).

VONVENDI is a novel recombinant protein treatment that includes a physiologic distribution of multimer proteins, the most active form of the protein supporting clot formation. The treatment is also the first in the U.S. that contains only trace amounts of Factor VIII (FVIII), offering the flexibility to administer FVIII only when needed. This allows for tailored treatment for patients who may not require additional FVIII.

VWD is the most common inherited bleeding disorder worldwide, affecting as many as one in 100 people; the rarest and often most severe form affects one in 1,000,000 people worldwide. This genetic disorder causes alterations or deficits in von Willebrand factor (VWF), resulting in impaired clotting.