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.


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Reference

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.