Supplemental approval from PMDA (Japan) for Vonvendi to treat von Willebrand disease.-Takeda
The Pharmaceuticals and Medical Devices Agency (PMDA)(Japan) on March 29 announced a label update for Takeda Pharmaceutical’s Vonvendi (vonicog alfa), a treatment for von Willebrand disease (VWD).
VWD is an inherited disease characterized by a missing or defective blood-clotting protein called von Willebrand factor (VWF). Vonvendi’s label previously stated that the safety and efficacy of dosage regimens for routine administration intended for VWF replacement have not been established, except in cases of bleeding or perioperative settings. This statement was erased, and dosage regimens for routine administration were newly added for the prophylaxis of bleeding episodes. The change rides on the back of data from a clinical study, 071301, which investigated the drug as a prophylactic treatment for patients with severe VWD.
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