FDA Approves Takeda's Vonvendi As Prophylactic Treatment In Bleeding Disorder

The FDA has approved Takeda Pharmaceutical Co Ltd's TAK Vonvendi [von Willebrand factor (Recombinant)] for routine prophylaxis to reduce the frequency of bleeding episodes in Type 3 von Willebrand disease (VWD) receiving on-demand therapy.

• Vonvendi is the only recombinant von Willebrand factor (VWF) replacement therapy and the first and only treatment to reduce the frequency of bleeding episodes for severe Type 3 VWD approved by the FDA for routine prophylactic use. 
• Related content: Benzinga's Full FDA Calendar.
• Vonvendi is now indicated for routine prophylaxis in adults with severe Type 3 VWD receiving on-demand therapy and on-demand and perioperative bleed management in adults with VWD.
• VWD is an inherited disorder caused by a deficiency or impaired function of VWF, one of several types of proteins in the blood that are needed for proper blood clotting.
• Vonvendi is an infused product specifically designed to replace the body's missing or dysfunctional VWF.
• The approval is based on a prospective, open-label, international multicenter study. 
• The median annualized bleeding rates (ABR) for all bleeds was reduced from historical median ABR 5.0 to an on-study median ABR of 2.3, equivalent to a 54.7% reduction. 
• Price Action: TAK shares are up 0.10% at $14.41 during the market session on the last check Monday.