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Posted 12 Dec 2015 by Drugs.com
TUESDAY, Dec. 8, 2015 – Vonvendi has been approved to treat adults with von Willebrand disease (VWD), the most common inherited bleeding disorder. VWD, affecting about 1 percent of the U.S. population, is caused by lack of a protein that's essential for blood clotting. People with the disorder can develop severe bleeding from the nose, gums, intestines, muscles and joints. Women with VWD also can bleed excessively after a menstrual period or after giving birth. Vonvendi, a genetically engineered (recombinant) form of the missing protein, was evaluated in clinical studies of 69 adults with VWD. Itching was the most common side effect, the FDA said Tuesday in a news release. Vonvendi is produced by Baxalta, based in Westlake Village, Calif. More information Visit the FDA to learn more. Read more
FDA Approves Vonvendi (Von Willebrand Factor (Recombinant)) to Treat Bleeding Episodes in Patients with VWD
Posted 10 Dec 2015 by Drugs.com
December 8, 2015 – The U.S. Food and Drug Administration today approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with VWD. VWD is the most common inherited bleeding disorder, affecting approximately 1 percent of the U.S. population. Men and women are equally affected by VWD, which is caused by a deficiency or defect in von Willebrand factor, a protein that is critical for normal blood clotting. Patients with VWD can develop severe bleeding from the nose, gums, and intestines, as well as into muscles and joints. Women with VWD may have heavy menstrual periods lasting longer than average and may experience excessive ... Read more