Takeda announces FDA approval of Vonvendi for prophylaxis in bleeding disorder

  • Takeda Pharmaceutical (NYSE:TAK) announced that the FDA approved its oral therapeutic, Vonvendi, for routine prophylaxis in patients with severe Type 3 von Willebrand disease (VWD) receiving on-demand therapy.
  • Vonvendi is the only recombinant von Willebrand factor (VWF) replacement therapy indicated in the U.S. for prophylaxis in type 3 VWD patients reduce their frequency of bleeding episodes, the company said.
  • With an estimated three million patients, VWD is among the most common inherited bleeding disorders in the U.S.
  • The FDA approval was based on data from a prospective, open-label, multicenter study designed to evaluate the safety and efficacy of Vonvendi prophylactically in 10 adults with severe Type 3 VWD, who previously received on-demand therapy.
  • Vonvendi was developed by Shire PLC, which was acquired by Takeda (TAK) in 2019 following a $62B deal.

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