Baxalta announced that FDA has approved Vonvendi [von Willebrand factor (Recombinant)]. Vonvendi has been approved for on-demand treatment and control of bleeding episodes in adults with von Willebrand disease. Vonvendi is an innovative recombinant protein treatment that includes a physiologic distribution of proteins called multimers, including ultra-large multimers (ULMs), with large multimers being the most active form of the protein supporting clot formation. The treatment is also the first in the United States that contains only trace amounts of Factor VIII (FVIII), offering the flexibility to administer FVIII only when needed. This attribute allows for tailored treatment for patients who may not require additional FVIII.

Adverse Reactions: The most common adverse reaction observed in ≥2% of subjects in clinical trials (n=66) was generalized pruritis.

Citation: Baxalta Receives FDA Approval for VONVENDI, the First and Only Recombinant Treatment for Adults Affected by Von Willebrand Disease. [news release]. Bannockburn, IL: Baxalta; December 8, 2015. http://newsroom.baxalta.com/press-releases/press-release-details/2015/Baxalta-Receives-FDA-Approval-for-VONVENDI-the-First-and-Only-Recombinant-Treatment-for-Adults-Affected-by-Von-Willebrand-Disease/default.aspx. Accessed December 14, 2015.