WFH NETWORK

Surgical indication approved for WILATE

In August, the U.S. Food and Drug Administration (FDA) revised the product label for WILATE to include prevention of excessive bleeding during and after minor and major surgery in adults and children with von Willebrand disease (VWD).

This change expands the FDA license for WILATE, which formerly included only the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe VWD, as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.

WILATE is a plasma-derived clotting factor concentrate manufactured by Octapharma that contains von Willebrand factor and factor VIII. VWD is an inherited bleeding disorder – the most frequent of the rare bleeding disorders affecting about one percent of the population.

The international clinical trial on which the label change is based included patients with all types of VWD. The study reported a 100 per cent success rate in surgical procedures for Type 3 patients, the most serious form of VWD. For more information on VWD and the different severities, see WFH website.

http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM193127.pdf

http://www.wilateusa.com/index.php/news-a-events-22/130-octapharma-usa-fda-approves-wilate-license-supplement