Vonvendi Launched for von Willebrand Disease
Shire announced the launch of Vonvendi (von Willebrand factor [recombinant]; Baxalta) indicated for on-demand treatment and control of bleeding episodes in patients aged ≥18 years with von Willebrand disease.
Vonvendi, the first recombinant von Willebrand factor treatment, works by replacing the factor that is missing in von Willebrand disease. The product is also the first to allow dosing of the recombinant von Willebrand factor independent of recombinant factor VIII (FVIII), based on patient need. Vonvendi promotes homeostasis by mediating platelet adhesion to damaged vascular sub-endothelial matrix and platelet aggregation, and acts as a carrier protein for FVIII, protecting it from rapid proteolysis.
Vonvendi was initially approved by the Food and Drug Administration (FDA) in December 2015. Its approval was based on data from Phase 3 multicenter, open-label clinical study that evaluated the safety, efficacy, and pharmacokinetics of Vonvendi with and without recombinant FVIII. Successful treatment of bleeding episodes was seen in all (100%) study patients.
Vonvendi is available as single-use vials in the following product strengths (von WIllebrand factor to Ristocetin cofactor assay ratio): 450–850 IU per vial and 900–1700 IU per vial. Vonvendi is packaged with sterile water for injection and a reconstitution device.
For more information call (800) 999-1785 or visit Vonvendi.com.