Approved for the as-needed treatment and control of bleeding episodes in adults
TUESDAY, Dec. 8, 2015 (HealthDay News) — Vonvendi has been approved by the U.S. Food and Drug Administration to treat adults with von Willebrand disease (VWD).
Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the as-needed treatment and control of bleeding episodes in adults diagnosed with VWD.
According to the FDA, Vonvendi was evaluated in clinical studies of 69 adults with VWD, and was found to be safe and effective for the on-demand treatment and control of bleeding episodes from a variety of different sites in the body. Generalized pruritus was the most common side effect.
“Patients with heritable bleeding disorders should meet with their health care provider to discuss appropriate measures to reduce blood loss,” Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The approval of Vonvendi provides an additional therapeutic option for the treatment of bleeding episodes in patients with von Willebrand disease.”
Vonvendi is produced by Baxalta, based in Westlake Village, Calif.
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