Takeda : FDA Oks Prophylactic Treatment With Vonvendi For Adult Patients With Severe Type 3 VWD

Takeda Pharmaceutical Company Limited (TAK) said that the U.S. Food & Drug Administration approved Vonvendi [von Willebrand factor (Recombinant)] for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease or 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.

Vonvendi is now indicated for routine prophylaxis in adults with severe Type 3 VWD receiving on-demand therapy, as well as on-demand and perioperative bleed management in adults with VWD.

von Willebrand disease is an inherited disorder that affects women and men equally. It is caused by a deficiency or defective function of VWF, one of several types of proteins in the blood that are needed for proper blood clotting. Due to this defective function or deficiency, blood is not able to clot effectively in people with VWD.

Vonvendi is an infused product that is specifically designed to replace the body's missing or dysfunctional VWF.

Vonvendi is used in adults diagnosed with von Willebrand disease to treat and control bleeding episodes; prevent excessive bleeding during and after surgery; reduce the number of bleeding episodes when used regularly (prophylaxis) in adults with severe Type 3 von Willebrand disease receiving on-demand therapy.

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