FDA Oks First Recombinant Von Willebrand Factor To Treat Bleeding Episodes

(RTTNews) - Baxalta Inc. (BXLT), announced today that the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (Recombinant)]. VONVENDI is the first and only recombinant treatment for adults living with von Willebrand Disease or VWD.

VONVENDI has been approved for on-demand treatment and control of bleeding episodes in adults with von Willebrand disease.

VONVENDI is expected to be broadly available in the United States in late 2016. Baxalta expects to file for regulatory approvals in Europe in 2017 and in other markets around the world.

VONVENDI is a recombinant protein treatment that includes a physiologic distribution of proteins called multimers, including ultra-large multimers (ULMs), with large multimers being the most active form of the protein supporting clot formation. The treatment is also the first in the United States that contains only trace amounts of Factor VIII (FVIII), offering the flexibility to administer FVIII only when needed. This attribute allows for tailored treatment for patients who may not require additional FVIII.

VWD is the most common inherited bleeding disorder worldwide, affecting up to one in 100 people; the rarest and often most severe form affects one in 1,000,000 people worldwide.