Vonvendi Receives New Indication
April 17, 2018 – The U.S. FDA has approved a new indication for Vonvendi® [von Willebrand factor (recombinant)], manufactured by Shire. The drug is now approved to provide management of perioperative bleeding in adult patients who have von Willebrand disease (VWD).
First approved in 2015 for on-demand treatment and control of bleeding episodes in patients with VWD, Vonvendi received its new indication based on a clinical trial that evaluated the safety and efficacy of the drug when used in elective surgical procedures for adults with severe VWD.
Von Willebrand disease is the most common form of inherited bleeding disorder. It affects an estimated 1.4 million Americans. The condition leads to the lack or poor function of a protein that helps blood to clot. This can result in bruising, prolonged bleeding, and in women, heavy or prolonged menstrual periods. Although the disease is equally present in men and women, women are more likely to demonstrate symptoms, due to the risk of increased bleeding related to menstrual periods, pregnancy, and childbirth.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.