Takeda Announces Approval of Prophylactic Indication for VWD Therapy

Takeda recently announced that the U.S. Food and Drug Administration (FDA) has approved VONVENDI® for routine prophylaxis to reduce the frequency of bleeding episodes in adults with severe Type 3 von Willebrand disease (VWD) receiving on-demand therapy. Type 3 VWD is the rarest and most severe form of the disease.

VONVENDI® is the only currently available recombinant von Willebrand factor therapy on the market.

“VWD is a complex disease where both patients and providers may experience stress and uncertainty due to the unpredictable disease course and limited treatment options,” said Miguel A. Escobar, MD, professor in the Department of Pediatrics and Internal Medicine at the McGovern Medical School at The University of Texas Health Science Center at Houston and an investigator in the VONVENDI prophylaxis study*. “A prophylactic treatment option may allow for greater disease control and the potential to enhance the standard of care.”

The new FDA approval represents an expanded indication for VONVENDI®, which was first approved in 2015 for the on-demand treatment and control of bleeding episodes in adults 18 and older with VWD.

Access this link to read the full press release.

Source: National Hemophilia Foundation