The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Vonvendi® (von Willebrand factor [recombinant]) for prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults 18 years of age and older with von Willebrand disease (VWD).
Vonvendi, a recombinant von Willebrand factor, is currently indicated for use in adults with VWD for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding.
The sBLA submission is supported by data from a prospective, open-label, non-randomized, multicenter, phase 3 study (ClinicalTrials.gov Identifier: NCT02973087) that assessed the efficacy and safety of prophylactic treatment with Vonvendi in adults with severe VWD over a period of 12 months. Results from the study will be presented at the International Society of Thrombosis and Haemostasis (ISTH) Congress on July 20, 2021.
A Prescription Drug User Fee Act (PDUFA) target date of January 28, 2022 has been set for this application.
U.S. Food and Drug Administration accepts Takeda’s supplemental Biologics License Application for adult prophylactic use of Vonvendi® [von Willebrand factor (recombinant)]. [press release]. Cambridge, MA: Takeda Pharmaceutical Company Limited; June 14, 2021.