On December 8, 2015, the US Food and Drug Administration (FDA) approved Vonvendi (vonicog alfa), the first recombinant von Willebrand factor therapy. The new product is approved for the on-demand treatment and control of bleeding episodes in adults 18 and older who have von Willebrand disease (VWD). Vonvendi is manufactured by Baxalta.
The FDA approval was based in large part on two successful trials, which included 69 adult patients with VWD. Investigators found that Vonvendi effectively treated bleeding episodes from a variety of different sites in the body. Most bleeds (81%) resolved with a single infusion. No safety concerns were reported. The most common side effect was itching.
“Patients with heritable bleeding disorders should meet with their health care provider to discuss appropriate measures to reduce blood loss,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Vonvendi provides an additional therapeutic option for the treatment of bleeding episodes in patients with von Willebrand disease.”
Source: FDA news release dated December 8, 2015
