Octapharma’s human plasma-derived von Willebrand Factor (VWF)/Factor VIII replacement product Wilate® has been granted expanded approval for prophylaxis by the U.S. Food and Drug Administration (FDA) to include all types of von Willebrand disease (VWD).
According to a new press release, the approved label now includes routine prophylaxis aimed at reducing the frequency of bleeding episodes in adults and children aged six and older with any type of VWD. Wilate®, which received its initial FDA approval in 2009, is also indicated for the on-demand treatment of bleeding episodes. Go to the FDA website for more product information.
The expanded approval was granted in light of a successful multicenter phase 3 trial that investigated the efficacy and safety of Wilate® prophylaxis over 12 months in people aged six and older with severe VWD of any type.
"Long-term prophylaxis with VWF concentrate, as compared to on-demand treatment for bleeding, is recommended for patients with severe VWD," according to Shveta Gupta, MD, a specialist in pediatric hematology and oncology with The Haley Center for Children's Cancer and Blood Disorders at Orlando Health Arnold Palmer Hospital for Children. "The approval of Wilate® for VWD prophylaxis is a welcome new treatment option that can be life-saving for many patients. Increased use of VWF prophylaxis in VWD patients may lead to improved patient care and a reduced burden of disease."
Visit the NBDF to learn more about von Willebrand disease.
