Beijing News (Reporter Zhang Zhaohui) On August 5, the official website of the National Medical Products Administration announced that the marketing application for Vonicog alfa for injection (Vonicoagulase α for injection) submitted by Takeda had been approved.
Public information shows that Vonicog alfa for injection is a recombinant von Willebrand factor. The indication approved in China this time is for on-demand treatment and bleeding event control in adult patients with von Willebrand disease (18 years and above), as well as perioperative bleeding management.
Von Willebrand disease is one of the common hereditary bleeding disorders, primarily caused by mutations in the von Willebrand factor (VWF) gene, leading to a reduced quantity or abnormal quality of von Willebrand factor in plasma. When the von Willebrand factor is dysfunctional or deficient, blood cannot clot effectively, and patients may experience varying degrees of bleeding manifestations, with severe cases potentially resulting in visceral bleeding. Additionally, patients with von Willebrand disease who require surgery face higher risks of bleeding as well as complications such as thrombosis.
As one of the important plasma components in the human body, von Willebrand Factor (VWF) mediates platelet adhesion to vascular injury sites and acts as a carrier for coagulation factor VIII (FVIII), stabilizing FVIII. Injectable vonicog alfa is a recombinant von Willebrand factor. It contains full-length VWF multimers, including ultra-large multimers, has a long half-life, and can effectively serve as a replacement therapy for von Willebrand disease while providing patients with personalized bleeding control methods.
Currently, Vonicog alfa for injection has been approved and launched in the United States, Canada, the United Kingdom, Switzerland, Australia, and Japan for on-demand treatment and bleeding event control in adult patients with von Willebrand disease, as well as perioperative bleeding management. In January 2023, the Center for Drug Evaluation of the National Medical Products Administration accepted the marketing application for Vonicog alfa for injection and granted it priority review for the on-demand treatment and bleeding event control in adult patients (aged 18 years and above) diagnosed with von Willebrand disease, as well as perioperative bleeding management.
Proofread by Baoqing Liu