Vonvendi receives expanded use approval by FDA

The FDA granted expanded use of von Willebrand factor for adults and certain children with von Willebrand disease.

Von Willebrand factor (recombinant; Vonvendi, Takeda) — approved by the FDA in 2015 — is the only recombinant treatment for von Willebrand disease in the U.S. It also is the first recombinant product approved for use in pediatric patients in the U.S.

The FDA granted expanded use of von Willebrand factor for adults and certain children with von Willebrand disease.

The agent was previously approved for on-demand treatment of bleeding episodes and perioperative use in adults, as well as perioperative use in adults with type 3 von Willebrand disease.

“This approval demonstrates FDA flexibility in evaluating applications of therapeutics to treat rare diseases,” Vinay Prasad, M