Posted from: Monday, December 28, 2015 - 10:35 AM - Present

Vonvendi Approved for the Treatment of von Willebrand Disease

December 8, 2015 – The U.S. Food and Drug Administration (FDA) approved Vonvendi, manufactured by Baxalta for the on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand Disease (VWD).  Usually, the bleeding disorder is characterized by the body’s inability to produce von Willebrand factor, which is a protein necessary to help clotting of blood. VWD is said to affect about 1-2% of the U.S. population. Vonvendi is the first recombinant treatment for adults with VWD, and is recommended to be administered via intravenous infusion in an initial dose of 40 to 80 international units (IU) per kg of body weight. Based on the extent and location of bleeding, the dosage may be adjusted, and if the patient’s factor VIII levels are unknown or below 40%, it is recommended that Vonvendi be used in combination with an infused recombinant factor VIII product. The dosage forms available for Vonvendi is lyophilized powder in single-use vials containing 650 or 1300 international units (IU) per vial of von Willebrand factor for intravenous use after reconstitution. Vonvendi is expected to be launched by the end of 2016 and will be available through a limited specialty network. 

 

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Last Updated Wednesday, December 13, 2017 - 06:45 AM.